Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

List of Devices for Third Party Review
  • Print
  • Share
  • E-mail
-
see related
Database updated April 22, 2024

This page lists devices currently eligible for third-party review under the FDA's 510(k) Third Party Review Program, formally, the Accredited Persons Program. Premarket Notifications ["510(k)'s"] for devices on this list can be submitted to FDA-recognized 3P510K Review Organizations (Accredited Persons) in lieu of FDA. Information on the 510(k) Third Party Review Program, including links to this page and to a list of accredited persons, is available at the 510(k) Third Party Review Program website.

How to use the list of eligible devices

The list has four columns:

  • The first column provides the classification regulation number for each device from Title 21, Code of Federal Regulations (CFR), Parts 862-892. A classification regulation identifies a generic type of device and specifies the regulatory class that fda has assigned to the device.
  • The second and third columns show the classification name for the device from the CFR, and the class of the device, respectively. In the second column, under each classification regulation name, one or more 3-letter product codes appear, along with the device name associated with each product code. Product codes represent specific subsets of devices grouped under the same classification regulation name. Manufacturers should determine the classification of their device at the product code level that most appropriately identifies their device(s).
  • The fourth column provides a link to available standards to assist manufacturers in the preparation-and 3P510k review organizations in the review-of 510(k)s for eligible devices.

Some important exceptions to the list

Please see the 510(k) Third Party Review Program Guidance for Industry, Food and Drug Administration Staff, and Third Party Review Organizations for exceptions to the list.


Obstetrics/Gynecology
help
Section No. Regulation Name
Product Code-Device Name		 Class
Available
Standards
866.6050 Ovarian adnexal mass assessment score test system.    
  ONX -  Ovarian Adnexal Mass Assessment Score Test System II
884.1050 Endocervical aspirator.    
  HFC -  Aspirator, Endocervical II
  PCF -  Sampler, Endocervical II
884.1060 Endometrial aspirator.    
  HFF -  Aspirator, Endometrial II
884.1100 Endometrial brush.    
  HFE -  Brush, Endometrial II
884.1175 Endometrial suction curette and accessories.    
  HHK -  Curette, Suction, Endometrial (And Accessories) II
884.1185 Endometrial washer.    
  HFD -  Washer, Endometrial II
884.1300 Uterotubal carbon dioxide insufflator and accessories.    
  HES -  Insufflator, Carbon-Dioxide, Uterotubal (And Accessories) II
884.1560 Fetal blood sampler.    
  HGW -  Sampler, Blood, Fetal II
884.1630 Colposcope.    
  HEX -  Colposcope (And Colpomicroscope) II
  MOK -  Vaginoscope And Accessories II
884.1660 Transcervical endoscope (amnioscope) and accessories.    
  HEZ -  Endoscope, Transcervical (Amnioscope)(And Accessories) II
884.1690 Hysteroscope and accessories.    
  HIH -  Hysteroscope (And Accessories) II
884.1700 Hysteroscopic insufflator.    
  HIG -  Insufflator, Hysteroscopic II
884.1720 Gynecologic laparoscope and accessories.    
  OCQ -  Laparoscopic Bladder-Neck Suspension Instrument, Stress Urinary Incontinence II
  NMH -  Laparoscope And Accessories, Gynecologic, Reprocessed II
884.1730 Laparoscopic insufflator.    
  NMI -  Laparoscopic Insufflator And Accessories, Reprocessed I
884.2225 Obstetric-gynecologic ultrasonic imager.    
  HEM -  Imager, Ultrasonic Obstetric-Gynecologic II
  HEN -  Caliper, Fetal Head, Ultrasonic II
  HHJ -  Locator, Intracorporeal Device, Ultrasonic, Obstetric-Gynecologic II
  HHX -  Holograph, Fetal, Acoustical II
884.2600 Fetal cardiac monitor.    
  KXN -  Monitor, Cardiac, Fetal II
884.2640 Fetal phonocardiographic monitor and accessories.    
  HFP -  Monitor, Phonocardiographic, Fetal II
884.2660 Fetal ultrasonic monitor and accessories.    
  HEI -  Monitor, Heart-Valve Movement, Fetal, Ultrasonic II
  HEJ -  Monitor, Hemic Sound, Ultrasonic II
  HEK -  Monitor, Heart Sound, Fetal, Ultrasonic II
  HEL -  Monitor, Heart Rate, Fetal, Ultrasonic II
  HEP -  Monitor, Blood-Flow, Ultrasonic II
  HEQ -  Monitor, Pressure, Arterial, Fetal, Ultrasonic II
  KNG -  Monitor, Ultrasonic, Fetal II
  LXE -  Doppler, Fetal, Ultrasound II
  MAA -  Monitor, Fetal Doppler Ultrasound II
884.2675 Fetal scalp circular (spiral) electrode and applicator.    
  HGP -  Electrode, Circular (Spiral), Scalp And Applicator II
884.2700 Intrauterine pressure monitor and accessories.    
  HFN -  Transducer, Pressure, Intrauterine II
  HFO -  Recorder, Pressure, Intrauterine II
  HGS -  Catheter, Intrauterine And Introducer II
  KXO -  Monitor, Pressure, Intrauterine II
884.2720 External uterine contraction monitor and accessories.    
  HFM -  Monitor, Uterine Contraction, External (For Use In Clinic) II
884.2740 Perinatal monitoring system and accessories.    
  HGM -  System, Monitoring, Perinatal II
884.2960 Obstetric ultrasonic transducer and accessories.    
  HGL -  Transducer, Ultrasonic, Obstetric II
884.3575 Vaginal pessary.    
  HHW -  Pessary, Vaginal II
884.3900 Vaginal stent.    
  HDX -  Dilator, Vaginal II
  HFK -  Mold, Vaginal II
  KXP -  Stent, Vaginal II
884.4120 Gynecologic electrocautery and accessories.    
  HGI -  Electrocautery, Gynecologic (And Accessories) II
884.4150 Bipolar endoscopic coagulator-cutter and accessories.    
  HIN -  Coagulator-Cutter, Endoscopic, Bipolar (And Accessories) II
884.4160 Unipolar endoscopic coagulator-cutter and accessories.    
  HFG -  Coagulator, Laparoscopic, Unipolar (And Accessories) II
  HFH -  Coagulator, Hysteroscopic (And Accessories) II
  HFI -  Coagulator, Culdoscopic (And Accessories) II
  KNF -  Coagulator-Cutter, Endoscopic, Unipolar (And Accessories) II
884.4260 Hygroscopic Laminaria cervical dilator.    
  HDY -  Dilator, Cervical, Hygroscopic-Laminaria II
  PFJ -  Catheter, Balloon, Dilation Of Cervical Canal Prior To Labor II
  PKN -  Dilator, Cervical, Synthetic, Osmotic II
  PON -  Catheter, Balloon, Dilation Of Cervical Canal II
884.4340 Fetal vacuum extractor.    
  HDB -  Extractor, Vacuum, Fetal II
884.4500 Obstetric fetal destructive instrument.    
  HDI -  Hook, Destructive, Obstetrical II
  HFZ -  Craniotribe II
  HGA -  Cranioclast II
  HHN -  Cleidoclast II
  KNB -  Instrument, Destructive, Fetal, Obstetric II
884.4530 Obstetric-gynecologic specialized manual instrument.    
  HCZ -  Forceps, Surgical, Gynecological II
  HDC -  Tenaculum, Uterine II
  HDP -  Elevator, Uterine II
  HDZ -  Knife, Cervical Cone II
  HFX -  Clamp, Circumcision II
  HHO -  Screw, Fibroid, Gynecological II
  HHT -  Spatula, Cervical, Cytological II
  LBX -  Pelvimeter, Internal II
  LKF -  Cannula, Manipulator/Injector, Uterine II
  MOV -  Catheters, Salpingography II
  NMG -  Forceps, Biopsy, Gynecological, Reprocessed II
884.4550 Gynecologic surgical laser.    
  HHR -  Laser, Surgical, Gynecologic II
  LLW -  Laser, Neodymium:Yag For Gynecologic Use II
884.5070 Vacuum abortion system.    
  HGF -  Source, Abortion Unit, Vacuum II
  HGG -  Controller, Abortion Unit, Vacuum II
  HGH -  Cannula, Suction, Uterine II
  HHI -  System, Abortion, Vacuum II
884.5100 Obstetric anesthesia set.    
  HEE -  Set, Anesthesia, Paracervical II
  HEG -  Set, Anesthesia, Pudendal II
  KNE -  Set, Anesthesia, Obstetric II
884.5160 Powered breast pump.    
  HGX -  Pump, Breast, Powered II
884.5250 Cervical cap.    
  HDR -  Cap, Cervical II
884.5300 Condom.    
  HIS -  Condom II
  MOL -  Condom, Synthetic II
  MSC -  Barrier, Std, Oral Sex II
  NUC -  Lubricant, Personal II
884.5310 Condom with spermicidal lubricant.    
  LTZ -  Condom With Nonoxynol-9 II
884.5350 Contraceptive diaphragm and accessories.    
  HDW -  Diaphragm, Contraceptive (And Accessories) II
884.5460 Scented or scented deodorized menstrual tampon.    
  HIL -  Tampon, Menstrual, Scented, Deodorized II
884.5470 Unscented menstrual tampon.    
  HEB -  Tampon, Menstrual, Unscented II
884.6100 Assisted reproduction needles.    
  MQE -  Needle, Assisted Reproduction II
  NNB -  Needle, Reproduction, Assisted, Reprocessed II
884.6110 Assisted reproduction catheters.    
  MQF -  Catheter, Assisted Reproduction II
884.6120 Assisted reproduction accessories.    
  MQG -  Accessory, Assisted Reproduction II
884.6130 Assisted reproduction microtools.    
  MQH -  Microtools, Assisted Reproduction (Pipettes) II
884.6140 Assisted reproduction micropipette fabrication instruments.    
  MQI -  Microtool Fabrication, Assisted Reproduction II
884.6160 Assisted reproduction labware.    
  MQK -  Labware, Assisted Reproduction II
884.6170 Assisted reproduction water and water purification systems.    
  MTW -  System, Water, Reproduction, Assisted, And Purification II

-
-