1998 CFR Title 21, Volume

Title 21--Food and Drugs CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES--(Continued) PART 884--OBSTETRICAL AND GYNECOLOGICAL DEVICES
	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).
	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.
	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.
	884.2740	Perinatal monitoring system and accessories.
	884.2900	Fetal stethoscope.
	884.2960	Obstetric ultrasonic transducer and accessories.
	884.2980	Telethermographic system.
	884.2982	Liquid crystal thermographic system.
	884.3200	Cervical drain.
	884.3575	Vaginal pessary.
	884.3650	Fallopian tube prosthesis.
	884.3900	Vaginal stent.
	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.
	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.
	884.5225	Abdominal decompression chamber.
	884.5250	Cervical cap.
	884.5300	Condom.
	884.5310	Condom with spermicidal lubricant.
	884.5320	Glans sheath.
	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.