Part 884 - OBSTETRICAL 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.
§ 884.1710 Closed loop hysteroscopic insufflator with cutter-coagulator.
§ 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
§ 884.4050 Gynecologic laparoscopic power morcellation containment system.
§ 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.
§ 884.4350 Fetal head elevator.
§ 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.
§ 884.4910 Specialized surgical instrumentation for use with urogynecologic surgical mesh.
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.
§ 884.5210 Pressure wedge for the reduction of cesarean delivery.
§ 884.5225 Abdominal decompression chamber.
§ 884.5250 Cervical cap.
§ 884.5300 Condom.
§ 884.5310 Condom with spermicidal lubricant.
§ 884.5320 Glans sheath.
§ 884.5330 Multiple-use female condom.
§ 884.5340 Single-use internal 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.
§ 884.5980 Surgical mesh for transvaginal pelvic organ prolapse repair.
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.
§ 884.6165 Intravaginal culture system.
§ 884.6170 Assisted reproduction water and water purification systems.
§ 884.6180 Reproductive media and supplements.
§ 884.6190 Assisted reproductive microscopes and microscope accessories.
§ 884.6195 Assisted Reproduction Embryo Image Assessment System.
§ 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.