TITLE 21--FOOD AND DRUGS CHAPTER I--FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER H - MEDICAL 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.
§ 884.5370 - Software application for contraception.
§ 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.
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