Part 884 Subpart F—Obstetrical and Gynecological Therapeutic Devices

FDA submissions for Part 884 Subpart F—Obstetrical and Gynecological Therapeutic Devices in the Obstetrics/Gynecology (OB) review panel, including product codes and regulations.

Section range: §§ 884.5050–884.5980

CFR Part: 884

Product Codes

Product CodeDevice NameRegulationClassDevices
HHQSystem, Abortion, Metreurynter-Balloon884.505030
HGFSource, Abortion Unit, Vacuum884.507024
HGGController, Abortion Unit, Vacuum884.507021
HGHCannula, Suction, Uterine884.507026
HHISystem, Abortion, Vacuum884.5070224
HEESet, Anesthesia, Paracervical884.510029
HEGSet, Anesthesia, Pudendal884.510020
KNESet, Anesthesia, Obstetric884.510022
PVUObstetrical Anesthesia Kit884.510020
PVVParacervical Anesthesia Kit884.510020
PVWPudendal Anesthesia Kit884.510020
HGYPump, Breast, Non-Powered884.5150127
PWABreast Pump Accessory, Milk Expression Aid, Via Positive Pressure884.515010
HGXPump, Breast, Powered884.51602234
OHHBreast Pump Kit884.516020
OOAHemorrhoid Prevention Pressure Wedge884.520021
PNUPressure Wedge, Perianal, For Reduction Of Cesarean Delivery884.521021
HEHChamber, Decompression, Abdominal884.522530
HDRCap, Cervical884.5250229
MFDCannula, Intrauterine Insemination884.5250229
OBBKit, Conception-Assist, Home Use884.525024
HISCondom884.53002400
MOLCondom, Synthetic884.5300223
MSCBarrier, Std, Oral Sex884.530026
NUCLubricant, Personal884.53002240
OKWSeminal Fluid Collection Kit884.530020
PEBLubricant, Personal, Gamete, Fertilization, And Embryo Compatible884.5300210
QPDPersonal Lubricant Ring884.530021
QRZExternal Condom For Anal Intercourse Or Vaginal Intercourse884.530521
LTZCondom With Nonoxynol-9884.5310222
LZLMicro-Condom884.532030
OBYCondom, Female, Animal Tissue884.533030
MBUSingle-Use Internal Condom884.534023
HDWDiaphragm, Contraceptive (And Accessories)884.535024
MPTContraception Calculator884.535021
HDTDevice, Intrauterine, Contraceptive And Introducer884.536030
PYTDevice, Fertility Diagnostic, Contraceptive, Software Application884.537026
HDOValve, Tubal Occlusion884.538030
HFYBand, Tubal Occlusion884.538030
HGBClip, Tubal Occlusion884.538030
HHSTranscervical Contraceptive Tubal Occlusion Device884.538031
KNHLaparoscopic Contraceptive Tubal Occlusion Device884.538034
HGZHeater, Perineal, Direct Contact884.539021
HHAHeater, Perineal, Radiant, Non-Contact884.539020
KNDHeater, Perineal884.539020
HHECup, Menstrual884.5400216
HHLPad, Menstrual, Scented, Scented-Deodorized884.5425257
NRCPad, Menstrual, Scented, Scented-Deodorized Made Of Common Cellulosic & Synthetic Material W/Established Safety Profile884.542510
HHDPad, Menstrual, Unscented884.54351136
NUQPad, Menstrual, Reusable884.543511
NURPad, Menstrual, Intralabial884.543510
PVTMaternity Kit884.543510
HIL Tampon, Menstrual, Scented, Scented-Deodorized884.5460284
HEBTampon, Menstrual, Unscented884.54702189
HEDDouche Apparatus, Vaginal, Therapeutic884.5900112
HECInsufflator, Vaginal884.592010
HIIStimulator, Vaginal, Muscle, Powered, For Therapeutic Use884.594030
KXQVibrator For Therapeutic Use, Genital884.596024
NBVDevice, Engorgement, Clitoral884.597023
OTPMesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed884.5980331
PAIMesh, Surgical, Non-Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed884.598032
Innolitics

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