Home/CFR/Title 21/Part 884
FEDERAL · 21 CFR

Part 884 — Obstetrical and Gynecological Devices

104 sections · Title 21: Food and Drugs

§ 884.1Scope.
§ 884.3Effective dates of requirement for premarket approval.
§ 884.9Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).
§ 884.1040Viscometer for cervical mucus.
§ 884.1050Endocervical aspirator.
§ 884.1060Endometrial aspirator.
§ 884.1100Endometrial brush.
§ 884.1175Endometrial suction curette and accessories.
§ 884.1185Endometrial washer.
§ 884.1300Uterotubal carbon dioxide insufflator and accessories.
§ 884.1425Perineometer.
§ 884.1550Amniotic fluid sampler (amniocentesis tray).
§ 884.1560Fetal blood sampler.
§ 884.1600Transabdominal amnioscope (fetoscope) and accessories.
§ 884.1630Colposcope.
§ 884.1640Culdoscope and accessories.
§ 884.1660Transcervical endoscope (amnioscope) and accessories.
§ 884.1690Hysteroscope and accessories.
§ 884.1700Hysteroscopic insufflator.
§ 884.1710Closed loop hysteroscopic insufflator with cutter-coagulator.
§ 884.1720Gynecologic laparoscope and accessories.
§ 884.1730Laparoscopic insufflator.
§ 884.2050Obstetric data analyzer.
§ 884.2225Obstetric-gynecologic ultrasonic imager.
§ 884.2600Fetal cardiac monitor.
§ 884.2620Fetal electroencephalographic monitor.
§ 884.2640Fetal phonocardiographic monitor and accessories.
§ 884.2660Fetal ultrasonic monitor and accessories.
§ 884.2675Fetal scalp circular (spiral) electrode and applicator.
§ 884.2685Fetal scalp clip electrode and applicator.
§ 884.2700Intrauterine pressure monitor and accessories.
§ 884.2720External uterine contraction monitor and accessories.
§ 884.2730Home uterine activity monitor.
§ 884.2740Perinatal monitoring system and accessories.
§ 884.2800Computerized Labor Monitoring System.
§ 884.2900Fetal stethoscope.
§ 884.2960Obstetric ultrasonic transducer and accessories.
§ 884.2980Telethermographic system.
§ 884.2982Liquid crystal thermographic system.
§ 884.2990Breast lesion documentation system.
§ 884.3200Cervical drain.
§ 884.3575Vaginal pessary.
§ 884.3650Fallopian tube prosthesis.
§ 884.3900Vaginal stent.
§ 884.4050Gynecologic laparoscopic power morcellation containment system.
§ 884.4100Endoscopic electrocautery and accessories.
§ 884.4120Gynecologic electrocautery and accessories.
§ 884.4150Bipolar endoscopic coagulator-cutter and accessories.
§ 884.4160Unipolar endoscopic coagulator-cutter and accessories.
§ 884.4250Expandable cervical dilator.
§ 884.4260Hygroscopic Laminaria cervical dilator.
§ 884.4270Vibratory cervical dilators.
§ 884.4340Fetal vacuum extractor.
§ 884.4350Fetal head elevator.
§ 884.4400Obstetric forceps.
§ 884.4500Obstetric fetal destructive instrument.
§ 884.4520Obstetric-gynecologic general manual instrument.
§ 884.4530Obstetric-gynecologic specialized manual instrument.
§ 884.4550Gynecologic surgical laser.
§ 884.4900Obstetric table and accessories.
§ 884.4910Specialized surgical instrumentation for use with urogynecologic surgical mesh.
§ 884.5050Metreurynter-balloon abortion system.
§ 884.5070Vacuum abortion system.
§ 884.5100Obstetric anesthesia set.
§ 884.5150Nonpowered breast pump.
§ 884.5160Powered breast pump.
§ 884.5200Hemorrhoid prevention pressure wedge.
§ 884.5210Pressure wedge for the reduction of cesarean delivery.
§ 884.5225Abdominal decompression chamber.
§ 884.5250Cervical cap.
§ 884.5300Condom.
§ 884.5310Condom with spermicidal lubricant.
§ 884.5320Glans sheath.
§ 884.5330Multiple-use female condom.
§ 884.5340Single-use internal condom.
§ 884.5350Contraceptive diaphragm and accessories.
§ 884.5360Contraceptive intrauterine device (IUD) and introducer.
§ 884.5370Software application for contraception.
§ 884.5380Contraceptive tubal occlusion device (TOD) and introducer.
§ 884.5390Perineal heater.
§ 884.5400Menstrual cup.
§ 884.5425Scented or scented deodorized menstrual pad.
§ 884.5435Unscented menstrual pad.
§ 884.5460Scented or scented deodorized menstrual tampon.
§ 884.5470Unscented menstrual tampon.
§ 884.5900Therapeutic vaginal douche apparatus.
§ 884.5920Vaginal insufflator.
§ 884.5940Powered vaginal muscle stimulator for therapeutic use.
§ 884.5960Genital vibrator for therapeutic use.
§ 884.5970Clitoral engorgement device.
§ 884.5980Surgical mesh for transvaginal pelvic organ prolapse repair.
§ 884.6100Assisted reproduction needles.
§ 884.6110Assisted reproduction catheters.
§ 884.6120Assisted reproduction accessories.
§ 884.6130Assisted reproduction microtools.
§ 884.6140Assisted reproduction micropipette fabrication instruments.
§ 884.6150Assisted reproduction micromanipulators and microinjectors.
§ 884.6160Assisted reproduction labware.
§ 884.6165Intravaginal culture system.
§ 884.6170Assisted reproduction water and water purification systems.
§ 884.6180Reproductive media and supplements.
§ 884.6190Assisted reproductive microscopes and microscope accessories.
§ 884.6195Assisted Reproduction Embryo Image Assessment System.
§ 884.6200Assisted reproduction laser system.