FDA医疗器械分类目录-第884部分妇产科器械

标题 21--食品和药品
第一章--食品和药物管理局
卫生与公众服务
部 分章 h 分章 - 医疗器械

第884部分妇产科器械

subpart b - obstetrical and gynecological diagnosticdevices
   § 884.1040 - viscometer for cervicalmucus.
   § 884.1050 - endocervical aspirator.
   § 884.1060 - endometrial aspirator.
   § 884.1100 - endometrial brush.
   § 884.1175 - endometrial suction curette andaccessories.
   § 884.1185 - endometrial washer.
   § 884.1300 - uterotubal carbon dioxideinsufflator 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 andaccessories.
   § 884.1700 - hysteroscopic insufflator.
   § 884.1710 - closed loop hysteroscopicinsufflator with cutter-coagulator.
   § 884.1720 - gynecologic laparoscope andaccessories.
   § 884.1730 - laparoscopic insufflator.

subpart c - obstetrical and gynecological monitoringdevices
   § 884.2050 - obstetric data analyzer.
   § 884.2225 - obstetric-gynecologicultrasonic imager.
   § 884.2600 - fetal cardiac monitor.
   § 884.2620 - fetal electroencephalographicmonitor.
   § 884.2640 - fetal phonocardiographicmonitor and accessories.
   § 884.2660 - fetal ultrasonic monitor andaccessories.
   § 884.2675 - fetal scalp circular (spiral)electrode and applicator.
   § 884.2685 - fetal scalp clip electrode andapplicator.
   § 884.2700 - intrauterine pressure monitorand accessories.
   § 884.2720 - external uterine contractionmonitor and accessories.
   § 884.2730 - home uterine activitymonitor.
   § 884.2740 - perinatal monitoring system andaccessories.
   § 884.2800 - computerized labor monitoringsystem.
   § 884.2900 - fetal stethoscope.
   § 884.2960 - obstetric ultrasonic transducerand accessories.
   § 884.2980 - telethermographic system.
   § 884.2982 - liquid crystal thermographicsystem.
   § 884.2990 - breast lesion documentationsystem.

subpart d - obstetrical and gynecological prostheticdevices
   § 884.3200 - cervical drain.
   § 884.3575 - vaginal pessary.
   § 884.3650 - fallopian tube prosthesis.
   § 884.3900 - vaginal stent.

subpart e - obstetrical and gynecological surgicaldevices
   § 884.4050 - gynecologic laparoscopic powermorcellation containment system.
   § 884.4100 - endoscopic electrocautery andaccessories.
   § 884.4120 - gynecologic electrocautery andaccessories.
   § 884.4150 - bipolar endoscopiccoagulator-cutter and accessories.
   § 884.4160 - unipolar endoscopiccoagulator-cutter and accessories.
   § 884.4250 - expandable cervicaldilator.
   § 884.4260 - hygroscopic laminaria cervicaldilator.
   § 884.4270 - vibratory cervicaldilators.
   § 884.4340 - fetal vacuum extractor.
   § 884.4350 - fetal head elevator.
   § 884.4400 - obstetric forceps.
   § 884.4500 - obstetric fetal destructiveinstrument.
   § 884.4520 - obstetric-gynecologic generalmanual instrument.
   § 884.4530 - obstetric-gynecologicspecialized manual instrument.
   § 884.4550 - gynecologic surgical laser.
   § 884.4900 - obstetric table andaccessories.
   § 884.4910 - specialized surgicalinstrumentation for use with urogynecologic surgical mesh.

subpart f - obstetrical and gynecological therapeuticdevices
   § 884.5050 - metreurynter-balloon abortionsystem.
   § 884.5070 - vacuum abortion system.
   § 884.5100 - obstetric anesthesia set.
   § 884.5150 - nonpowered breast pump.
   § 884.5160 - powered breast pump.
   § 884.5200 - hemorrhoid prevention pressurewedge.
   § 884.5210 - pressure wedge for thereduction of cesarean delivery.
   § 884.5225 - abdominal decompressionchamber.
   § 884.5250 - cervical cap.
   § 884.5300 - condom.
   § 884.5310 - condom with spermicidallubricant.
   § 884.5320 - glans sheath.
   § 884.5330 - multiple-use female condom.
   § 884.5340 - single-use internal condom.
   § 884.5350 - contraceptive diaphragm andaccessories.
   § 884.5360 - contraceptive intrauterinedevice (iud) and introducer.
   § 884.5370 - software application forcontraception.
   § 884.5380 - contraceptive tubal occlusiondevice (tod) and introducer.
   § 884.5390 - perineal heater.
   § 884.5400 - menstrual cup.
   § 884.5425 - scented or scented deodorizedmenstrual pad.
   § 884.5435 - unscented menstrual pad.
   § 884.5460 - scented or scented deodorizedmenstrual tampon.
   § 884.5470 - unscented menstrual tampon.
   § 884.5900 - therapeutic vaginal doucheapparatus.
   § 884.5920 - vaginal insufflator.
   § 884.5940 - powered vaginal musclestimulator for therapeutic use.
   § 884.5960 - genital vibrator fortherapeutic use.
   § 884.5970 - clitoral engorgementdevice.
   § 884.5980 - surgical mesh for transvaginalpelvic organ prolapse repair.

subpart g - assisted reproduction devices
   § 884.6100 - assisted reproductionneedles.
   § 884.6110 - assisted reproductioncatheters.
   § 884.6120 - assisted reproductionaccessories.
   § 884.6130 - assisted reproductionmicrotools.
   § 884.6140 - assisted reproductionmicropipette fabrication instruments.
   § 884.6150 - assisted reproductionmicromanipulators and microinjectors.
   § 884.6160 - assisted reproductionlabware.
   § 884.6165 - intravaginal culturesystem.
   § 884.6170 - assisted reproduction water andwater purification systems.
   § 884.6180 - reproductive media andsupplements.
   § 884.6190 - assisted reproductivemicroscopes and microscope accessories.
   § 884.6195 - assisted reproduction embryoimage assessment system.
   § 884.6200 - assisted reproduction lasersystem.