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Code of Federal Regulations (Last Updated: November 8, 2024) |
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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 - xxx |
| § 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. |