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Code of Federal Regulations (Last Updated: December 30, 2020) |
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Title 21 - Food and Drugs |
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CHAPTER I — FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES |
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SUBCHAPTER H — MEDICAL DEVICES |
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Part 884 - OBSTETRICAL AND GYNECOLOGICAL 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. |
Authority
21 U.S.C. 351, 360, 360c, 360e, 360j, 371.
Source
45 FR 12684–12720, Feb. 26, 1980, unless otherwise noted.