21 C.F.R. PART 884--OBSTETRICAL AND GYNECOLOGICAL DEVICES


TITLE 21--Food and Drugs

CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES

SUBCHAPTER H--MEDICAL DEVICES

PART 884--OBSTETRICAL AND GYNECOLOGICAL DEVICES

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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).
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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.
�884.1720
Gynecologic laparoscope and accessories.
�884.1730
Laparoscopic insufflator.
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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.
�884.2900
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.
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Subpart D--OBSTETRICAL AND GYNECOLOGICAL PROSTHETIC DEVICES

�884.3200
Cervical drain.
�884.3575
Vaginal pessary.
�884.3650
Fallopian tube prosthesis.
�884.3900
Vaginal stent.
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Subpart E--OBSTETRICAL AND GYNECOLOGICAL SURGICAL DEVICES

�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.
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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.
�884.5225
Abdominal decompression chamber.
�884.5250
Cervical cap.
�884.5300
Condom.
�884.5310
Condom with spermicidal lubricant.
�884.5320
Glans sheath.
�884.5330
Female 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.
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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.
�884.6170
Assisted reproduction water and water purification systems.
�884.6180
Reproductive media and supplements.
�884.6190
Assisted reproductive microscopes and microscope accessories.
�884.6200
Assisted reproduction laser system.
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