Anesthesiology
Review Panel
- CardiovascularReview Panel
- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- HematologyReview Panel
- ImmunologyReview Panel
- MicrobiologyReview Panel
- NeurologyReview Panel
- Obstetrical and GynecologicalReview Panel
- MiscellaneousMiscellaneous
- Subpart B—Clinical Chemistry Test SystemsCFR Sub-Part
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart B—Obstetrical and Gynecological Diagnostic DevicesCFR Sub-Part
- Subpart C—Cardiovascular Monitoring DevicesCFR Sub-Part
- Subpart C—Obstetrical and Gynecological Monitoring DevicesCFR Sub-Part
- Subpart D—Cardiovascular Prosthetic DevicesCFR Sub-Part
- Subpart D—Obstetrical and Gynecological Prosthetic DevicesCFR Sub-Part
- Subpart D—Physical Medicine Prosthetic DevicesCFR Sub-Part
- Subpart D—Prosthetic DevicesCFR Sub-Part
- Subpart E—Obstetrical and Gynecological Surgical DevicesCFR Sub-Part
- Subpart F—Obstetrical and Gynecological Therapeutic DevicesCFR Sub-Part
- HDOValve, Tubal Occlusion3Product Code
- HDRCap, Cervical2Product Code
- HDTDevice, Intrauterine, Contraceptive And Introducer3Product Code
- HDWDiaphragm, Contraceptive (And Accessories)2Product Code
- HEBTampon, Menstrual, Unscented2Product Code
- HECInsufflator, Vaginal1Product Code
- HEDDouche Apparatus, Vaginal, Therapeutic1Product Code
- HEESet, Anesthesia, Paracervical2Product Code
- HEGSet, Anesthesia, Pudendal2Product Code
- HEHChamber, Decompression, Abdominal3Product Code
- HFYBand, Tubal Occlusion3Product Code
- HGBClip, Tubal Occlusion3Product Code
- HGFSource, Abortion Unit, Vacuum2Product Code
- HGGController, Abortion Unit, Vacuum2Product Code
- HGHCannula, Suction, Uterine2Product Code
- HGXPump, Breast, Powered2Product Code
- HGYPump, Breast, Non-Powered1Product Code
- HGZHeater, Perineal, Direct Contact2Product Code
- HHAHeater, Perineal, Radiant, Non-Contact2Product Code
- HHDPad, Menstrual, Unscented1Product Code
- HHECup, Menstrual2Product Code
- HHISystem, Abortion, Vacuum2Product Code
- HHLPad, Menstrual, Scented2Product Code
- HHQSystem, Abortion, Metreurynter-Balloon3Product Code
- HHSTranscervical Contraceptive Tubal Occlusion Device3Product Code
- HIIStimulator, Vaginal, Muscle, Powered, For Therapeutic Use3Product Code
- HILTampon, Menstrual, Scented, Deodorized2Product Code
- HISCondom2Product Code
- KNDHeater, Perineal2Product Code
- KNESet, Anesthesia, Obstetric2Product Code
- KNHLaparoscopic Contraceptive Tubal Occlusion Device3Product Code
- KXQVibrator For Therapeutic Use, Genital2Product Code
- LTZCondom With Nonoxynol-92Product Code
- LZLMicro-Condom3Product Code
- MBUSingle-Use Internal Condom2Product Code
- MFDCannula, Intrauterine Insemination2Product Code
- NURPad, Interlabial1Product Code
- MOLCondom, Synthetic2Product Code
- MSCBarrier, Std, Oral Sex2Product Code
- NBVDevice, Engorgement, Clitoral2Product Code
- NRCPads, Menstrual, Scented-Deodorized1Product Code
- NUCLubricant, Personal2Product Code
- NUQPad, Menstrual, Reusable1Product Code
- OBBKit, Conception-Assist, Home Use2Product Code
- OBYCondom, Female, Animal Tissue3Product Code
- PEBLubricant, Personal, Gamete, Fertilization, And Embryo Compatible2Product Code
- OHHBreast Pump Kit2Product Code
- OKWSeminal Fluid Collection Kit2Product Code
- OOAHemorrhoid Prevention Pressure Wedge2Product Code
- OTPMesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed3Product Code
- PAIMesh, Surgical, Non-Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed3Product Code
- PNUPressure Wedge, Perianal, For Reduction Of Cesarean Delivery2Product Code
- PVTMaternity Kit1Product Code
- PVUObstetrical Anesthesia Kit2Product Code
- PVVParacervical Anesthesia Kit2Product Code
- PVWPudendal Anesthesia Kit2Product Code
- PWABreast Pump Accessory, Milk Expression Aid, Via Positive Pressure1Product Code
- PYTDevice, Fertility Diagnostic, Contraceptive, Software Application2Product Code
- QPDPersonal Lubricant Ring2Product Code
- Subpart F—Therapeutic DevicesCFR Sub-Part
- Subpart G—Assisted Reproduction DevicesCFR Sub-Part
- OphthalmicReview Panel
- OrthopedicReview Panel
- PathologyReview Panel
- Physical MedicineReview Panel
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
Breast Pump Kit
- Page Type
- Product Code
- Definition
- This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.
- Physical State
- This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.
- Technical Method
- This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.
- Target Area
- This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.
- Regulation Medical Specialty
- Obstetrical and Gynecological
- Review Panel
- Obstetrical and Gynecological
- Submission Type
- Enforcement Discretion
- Device Classification
- Class 2
- Regulation Number
- 884.5160
- GMP Exempt?
- No
- Summary Malfunction Reporting
- Eligible
- Implanted Device
- No
- Life-Sustain/Support Device
- No
- Third Party Review
- Not Third Party Eligible
- MAUDE Alerts
- View and Sign Up For MAUDE Alerts
CFR § 884.5160 Powered breast pump
§ 884.5160 Powered breast pump.
(a) Identification. A powered breast pump in an electrically powered suction device used to express milk from the breast.
(b) Classification. Class II (performance standards).