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Title 21 - Title 21

Part 884 - OBSTETRICAL AND GYNECOLOGICAL DEVICES

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Details about Part 884

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MEDICAL DEVICES - OBSTETRICAL AND GYNECOLOGICAL DEVICES

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104 sections

§884.1 - Scope.

Title 21, Part 884

§884.1040 - Viscometer for cervical mucus.

Title 21, Part 884

§884.1050 - Endocervical aspirator.

Title 21, Part 884

§884.1060 - Endometrial aspirator.

Title 21, Part 884

§884.1100 - Endometrial brush.

Title 21, Part 884

§884.1175 - Endometrial suction curette and accessories.

Title 21, Part 884

§884.1185 - Endometrial washer.

Title 21, Part 884

§884.1300 - Uterotubal carbon dioxide insufflator and accessories.

Title 21, Part 884

§884.1425 - Perineometer.

Title 21, Part 884

§884.1550 - Amniotic fluid sampler (amniocentesis tray).

Title 21, Part 884

§884.1560 - Fetal blood sampler.

Title 21, Part 884

§884.1600 - Transabdominal amnioscope (fetoscope) and accessories.

Title 21, Part 884

§884.1630 - Colposcope.

Title 21, Part 884

§884.1640 - Culdoscope and accessories.

Title 21, Part 884

§884.1660 - Transcervical endoscope (amnioscope) and accessories.

Title 21, Part 884

§884.1690 - Hysteroscope and accessories.

Title 21, Part 884

§884.1700 - Hysteroscopic insufflator.

Title 21, Part 884

§884.1710 - Closed loop hysteroscopic insufflator with cutter-coagulator.

Title 21, Part 884

§884.1720 - Gynecologic laparoscope and accessories.

Title 21, Part 884

§884.1730 - Laparoscopic insufflator.

Title 21, Part 884

§884.2050 - Obstetric data analyzer.

Title 21, Part 884

§884.2225 - Obstetric-gynecologic ultrasonic imager.

Title 21, Part 884

§884.2600 - Fetal cardiac monitor.

Title 21, Part 884

§884.2620 - Fetal electroencephalographic monitor.

Title 21, Part 884

§884.2640 - Fetal phonocardiographic monitor and accessories.

Title 21, Part 884

§884.2660 - Fetal ultrasonic monitor and accessories.

Title 21, Part 884

§884.2675 - Fetal scalp circular (spiral) electrode and applicator.

Title 21, Part 884

§884.2685 - Fetal scalp clip electrode and applicator.

Title 21, Part 884

§884.2700 - Intrauterine pressure monitor and accessories.

Title 21, Part 884

§884.2720 - External uterine contraction monitor and accessories.

Title 21, Part 884

§884.2730 - Home uterine activity monitor.

Title 21, Part 884

§884.2740 - Perinatal monitoring system and accessories.

Title 21, Part 884

§884.2800 - Computerized Labor Monitoring System.

Title 21, Part 884

§884.2900 - Fetal stethoscope.

Title 21, Part 884

§884.2960 - Obstetric ultrasonic transducer and accessories.

Title 21, Part 884

§884.2980 - Telethermographic system.

Title 21, Part 884

§884.2982 - Liquid crystal thermographic system.

Title 21, Part 884

§884.2990 - Breast lesion documentation system.

Title 21, Part 884

§884.3 - Effective dates of requirement for premarket approval.

Title 21, Part 884

§884.3200 - Cervical drain.

Title 21, Part 884

§884.3575 - Vaginal pessary.

Title 21, Part 884

§884.3650 - Fallopian tube prosthesis.

Title 21, Part 884

§884.3900 - Vaginal stent.

Title 21, Part 884

§884.4050 - Gynecologic laparoscopic power morcellation containment system.

Title 21, Part 884

§884.4100 - Endoscopic electrocautery and accessories.

Title 21, Part 884

§884.4120 - Gynecologic electrocautery and accessories.

Title 21, Part 884

§884.4150 - Bipolar endoscopic coagulator-cutter and accessories.

Title 21, Part 884

§884.4160 - Unipolar endoscopic coagulator-cutter and accessories.

Title 21, Part 884

§884.4250 - Expandable cervical dilator.

Title 21, Part 884

§884.4260 - Hygroscopic Laminaria cervical dilator.

Title 21, Part 884

§884.4270 - Vibratory cervical dilators.

Title 21, Part 884

§884.4340 - Fetal vacuum extractor.

Title 21, Part 884

§884.4350 - Fetal head elevator.

Title 21, Part 884

§884.4400 - Obstetric forceps.

Title 21, Part 884

§884.4500 - Obstetric fetal destructive instrument.

Title 21, Part 884

§884.4520 - Obstetric-gynecologic general manual instrument.

Title 21, Part 884

§884.4530 - Obstetric-gynecologic specialized manual instrument.

Title 21, Part 884

§884.4550 - Gynecologic surgical laser.

Title 21, Part 884

§884.4900 - Obstetric table and accessories.

Title 21, Part 884

§884.4910 - Specialized surgical instrumentation for use with urogynecologic surgical mesh.

Title 21, Part 884

§884.5050 - Metreurynter-balloon abortion system.

Title 21, Part 884

§884.5070 - Vacuum abortion system.

Title 21, Part 884

§884.5100 - Obstetric anesthesia set.

Title 21, Part 884

§884.5150 - Nonpowered breast pump.

Title 21, Part 884

§884.5160 - Powered breast pump.

Title 21, Part 884

§884.5200 - Hemorrhoid prevention pressure wedge.

Title 21, Part 884

§884.5210 - Pressure wedge for the reduction of cesarean delivery.

Title 21, Part 884

§884.5225 - Abdominal decompression chamber.

Title 21, Part 884

§884.5250 - Cervical cap.

Title 21, Part 884

§884.5300 - Condom.

Title 21, Part 884

§884.5310 - Condom with spermicidal lubricant.

Title 21, Part 884

§884.5320 - Glans sheath.

Title 21, Part 884

§884.5330 - Multiple-use female condom.

Title 21, Part 884

§884.5340 - Single-use internal condom.

Title 21, Part 884

§884.5350 - Contraceptive diaphragm and accessories.

Title 21, Part 884

§884.5360 - Contraceptive intrauterine device (IUD) and introducer.

Title 21, Part 884

§884.5370 - Software application for contraception.

Title 21, Part 884

§884.5380 - Contraceptive tubal occlusion device (TOD) and introducer.

Title 21, Part 884

§884.5390 - Perineal heater.

Title 21, Part 884

§884.5400 - Menstrual cup.

Title 21, Part 884

§884.5425 - Scented or scented deodorized menstrual pad.

Title 21, Part 884

§884.5435 - Unscented menstrual pad.

Title 21, Part 884

§884.5460 - Scented or scented deodorized menstrual tampon.

Title 21, Part 884

§884.5470 - Unscented menstrual tampon.

Title 21, Part 884

§884.5900 - Therapeutic vaginal douche apparatus.

Title 21, Part 884

§884.5920 - Vaginal insufflator.

Title 21, Part 884

§884.5940 - Powered vaginal muscle stimulator for therapeutic use.

Title 21, Part 884

§884.5960 - Genital vibrator for therapeutic use.

Title 21, Part 884

§884.5970 - Clitoral engorgement device.

Title 21, Part 884

§884.5980 - Surgical mesh for transvaginal pelvic organ prolapse repair.

Title 21, Part 884

§884.6100 - Assisted reproduction needles.

Title 21, Part 884

§884.6110 - Assisted reproduction catheters.

Title 21, Part 884

§884.6120 - Assisted reproduction accessories.

Title 21, Part 884

§884.6130 - Assisted reproduction microtools.

Title 21, Part 884

§884.6140 - Assisted reproduction micropipette fabrication instruments.

Title 21, Part 884

§884.6150 - Assisted reproduction micromanipulators and microinjectors.

Title 21, Part 884

§884.6160 - Assisted reproduction labware.

Title 21, Part 884

§884.6165 - Intravaginal culture system.

Title 21, Part 884

§884.6170 - Assisted reproduction water and water purification systems.

Title 21, Part 884

§884.6180 - Reproductive media and supplements.

Title 21, Part 884

§884.6190 - Assisted reproductive microscopes and microscope accessories.

Title 21, Part 884

§884.6195 - Assisted Reproduction Embryo Image Assessment System.

Title 21, Part 884

§884.6200 - Assisted reproduction laser system.

Title 21, Part 884

§884.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

Title 21, Part 884