Part 884 — Obstetrical and Gynecological Devices
Subpart A — General Provisions
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
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.