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Electronic Code of Federal Regulations

e-CFR data is current as of December 12, 2019

Title 21Chapter ISubchapter HPart 884


TITLE 21—Food and Drugs

CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED)

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.
§884.1710
Closed loop hysteroscopic insufflator with cutter-coagulator.
§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.
§884.2800
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.
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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

§884.4050
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.
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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.
§884.5200
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.
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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.
§884.6165
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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