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U.S. Department of Health and Human Services

List of Devices for Third Party Review

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Database updated November 29, 2021

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

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

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