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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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Help | More About 21CFR
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER H--MEDICAL DEVICES
 
PART 884OBSTETRICAL AND GYNECOLOGICAL DEVICES
 

Subpart A--General Provisions
   § 884.1 - Scope.
   § 884.3 - Effective dates of requirement for premarket approval.
   § 884.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

Subpart B--Obstetrical and Gynecological Diagnostic Devices
   § 884.1040 - Viscometer for cervical mucus.
   § 884.1050 - Endocervical aspirator.
   § 884.1060 - Endometrial aspirator.
   § 884.1100 - Endometrial brush.
   § 884.1175 - Endometrial suction curette and accessories.
   § 884.1185 - Endometrial washer.
   § 884.1300 - Uterotubal carbon dioxide insufflator and accessories.
   § 884.1425 - Perineometer.
   § 884.1550 - Amniotic fluid sampler (amniocentesis tray).
   § 884.1560 - Fetal blood sampler.
   § 884.1600 - Transabdominal amnioscope (fetoscope) and accessories.
   § 884.1630 - Colposcope.
   § 884.1640 - Culdoscope and accessories.
   § 884.1660 - Transcervical endoscope (amnioscope) and accessories.
   § 884.1690 - Hysteroscope and accessories.
   § 884.1700 - Hysteroscopic insufflator.
   § 884.1720 - Gynecologic laparoscope and accessories.
   § 884.1730 - Laparoscopic insufflator.

Subpart C--Obstetrical and Gynecological Monitoring Devices
   § 884.2050 - Obstetric data analyzer.
   § 884.2225 - Obstetric-gynecologic ultrasonic imager.
   § 884.2600 - Fetal cardiac monitor.
   § 884.2620 - Fetal electroencephalographic monitor.
   § 884.2640 - Fetal phonocardiographic monitor and accessories.
   § 884.2660 - Fetal ultrasonic monitor and accessories.
   § 884.2675 - Fetal scalp circular (spiral) electrode and applicator.
   § 884.2685 - Fetal scalp clip electrode and applicator.
   § 884.2700 - Intrauterine pressure monitor and accessories.
   § 884.2720 - External uterine contraction monitor and accessories.
   § 884.2730 - Home uterine activity monitor.
   § 884.2740 - Perinatal monitoring system and accessories.
   § 884.2800 - Computerized Labor Monitoring System.
   § 884.2900 - Fetal stethoscope.
   § 884.2960 - Obstetric ultrasonic transducer and accessories.
   § 884.2980 - Telethermographic system.
   § 884.2982 - Liquid crystal thermographic system.
   § 884.2990 - Breast lesion documentation system.

Subpart D--Obstetrical and Gynecological Prosthetic Devices
   § 884.3200 - Cervical drain.
   § 884.3575 - Vaginal pessary.
   § 884.3650 - Fallopian tube prosthesis.
   § 884.3900 - Vaginal stent.

Subpart E--Obstetrical and Gynecological Surgical Devices
   § 884.4100 - Endoscopic electrocautery and accessories.
   § 884.4120 - Gynecologic electrocautery and accessories.
   § 884.4150 - Bipolar endoscopic coagulator-cutter and accessories.
   § 884.4160 - Unipolar endoscopic coagulator-cutter and accessories.
   § 884.4250 - Expandable cervical dilator.
   § 884.4260 - Hygroscopic Laminaria cervical dilator.
   § 884.4270 - Vibratory cervical dilators.
   § 884.4340 - Fetal vacuum extractor.
   § 884.4400 - Obstetric forceps.
   § 884.4500 - Obstetric fetal destructive instrument.
   § 884.4520 - Obstetric-gynecologic general manual instrument.
   § 884.4530 - Obstetric-gynecologic specialized manual instrument.
   § 884.4550 - Gynecologic surgical laser.
   § 884.4900 - Obstetric table and accessories.

Subpart F--Obstetrical and Gynecological Therapeutic Devices
   § 884.5050 - Metreurynter-balloon abortion system.
   § 884.5070 - Vacuum abortion system.
   § 884.5100 - Obstetric anesthesia set.
   § 884.5150 - Nonpowered breast pump.
   § 884.5160 - Powered breast pump.
   § 884.5200 - Hemorrhoid prevention pressure wedge.
   § 884.5225 - Abdominal decompression chamber.
   § 884.5250 - Cervical cap.
   § 884.5300 - Condom.
   § 884.5310 - Condom with spermicidal lubricant.
   § 884.5320 - Glans sheath.
   § 884.5330 - Female condom.
   § 884.5350 - Contraceptive diaphragm and accessories.
   § 884.5360 - Contraceptive intrauterine device (IUD) and introducer.
   § 884.5380 - Contraceptive tubal occlusion device (TOD) and introducer.
   § 884.5390 - Perineal heater.
   § 884.5400 - Menstrual cup.
   § 884.5425 - Scented or scented deodorized menstrual pad.
   § 884.5435 - Unscented menstrual pad.
   § 884.5460 - Scented or scented deodorized menstrual tampon.
   § 884.5470 - Unscented menstrual tampon.
   § 884.5900 - Therapeutic vaginal douche apparatus.
   § 884.5920 - Vaginal insufflator.
   § 884.5940 - Powered vaginal muscle stimulator for therapeutic use.
   § 884.5960 - Genital vibrator for therapeutic use.
   § 884.5970 - Clitoral engorgement device.

Subpart G--Assisted Reproduction Devices
   § 884.6100 - Assisted reproduction needles.
   § 884.6110 - Assisted reproduction catheters.
   § 884.6120 - Assisted reproduction accessories.
   § 884.6130 - Assisted reproduction microtools.
   § 884.6140 - Assisted reproduction micropipette fabrication instruments.
   § 884.6150 - Assisted reproduction micromanipulators and microinjectors.
   § 884.6160 - Assisted reproduction labware.
   § 884.6170 - Assisted reproduction water and water purification systems.
   § 884.6180 - Reproductive media and supplements.
   § 884.6190 - Assisted reproductive microscopes and microscope accessories.
   § 884.6200 - Assisted reproduction laser system.

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.
Source: 45 FR 12684-12720, Feb. 26, 1980, unless otherwise noted.

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