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
- K071827ALWAYS MENSTRUAL PADS1Cleared 510(K)
- K012629ALWAYS DUETS1Cleared 510(K)
- K003843ENVIVE MINIFORMS1Cleared 510(K)
- K993870UNSCENTED INTERLABIAL MENSTRUAL PAD1Cleared 510(K)
- K980395GLADRAGS COTTON MENSTRUAL PAD1Cleared 510(K)
- K953470FLUSHIES FLUSHABLE/BIODEGRADABLE MENSTRUAL PADS/NAPKINS (ULTRA THINS)1Cleared 510(K)
- K953667UNSCENTED CURVED ULTRATHIN MAXI PADS1Cleared 510(K)
- K953668UNSCENTED ULTRATHIN MAXI PAD1Cleared 510(K)
- K953633UNSCENTED MENSTRUAL PAD1Cleared 510(K)
- K953553UNSCENTED MENSTRAL PAD1Cleared 510(K)
- K953517UNSCENTED MENSTRUAL PAD1Cleared 510(K)
- K953700UNSCENTED CURVED MAXI PAD1Cleared 510(K)
- K953666UNSCENTED MENSTRAL PAD WITH WINGS1Cleared 510(K)
- K953487UNSCENTED MENSTRUAL SHIELD1Cleared 510(K)
- K953488UNSCENTED MENSTRUAL LINER1Cleared 510(K)
- K951693CARESS SANITARY NAPKIN1Cleared 510(K)
- K924502REUSABLE MENSTRUAL PAD1Cleared 510(K)
- K942814SELF SUPER MAXI SNAITARY NAPKINS1Cleared 510(K)
- K940468FEMININE MAXI PADS1Cleared 510(K)
- K922911OPTIONS COMFORT CURVES CLOTH MENSTRUAL PAD SYSTEM1Cleared 510(K)
- K940329NATRACARE MENSTRUAL PADS1Cleared 510(K)
- K935562PANTY LINERS1Cleared 510(K)
- K933950LADY'S CARE MAXI PADS1Cleared 510(K)
- K940377UNSCENTED MENSTRUAL PAD TIER-1 REVIEW1Cleared 510(K)
- K933879PADS MENSTRUAL, UNTREAT DEODORIZED, VARIOUS SIZES1Cleared 510(K)
- K934662UNSCENTED MENSTRUAL PAD1Cleared 510(K)
- K924176SABA INTIMA1Cleared 510(K)
- K924175SABA CONFORT1Cleared 510(K)
- K924177CONFORT1Cleared 510(K)
- K921115ULTRA THIN MENSTRUAL PAD1Cleared 510(K)
- K925250KOTEX(R) SECUREHOLD SUPER CURVE/CURVED MAXI PADS1Cleared 510(K)
- K922575ALWAYS CONTOURS UNSCENTED MENSTRUAL PADS1Cleared 510(K)
- K920830NEW FREEDOM ULTRA THIN PADS1Cleared 510(K)
- K913747STAYFREE(TM) MAXI-PAD1Cleared 510(K)
- K905178DELUXE SANITARY PAD1Cleared 510(K)
- K902273O. B. PACK III1Cleared 510(K)
- K902160SABA CONFORT MENSTRUAL PAD1Cleared 510(K)
- K901690WHENEVER(R) UNSCENTED SUPER MAXI PAD1Cleared 510(K)
- K902271O. B. PACK I1Cleared 510(K)
- K902272O. B. PACK II1Cleared 510(K)
- K901664CAREFREE(TM) FESTIVA PANTYSHIELDS1Cleared 510(K)
- K900421PROMISE ABSORBENT PROTECTIVE PAD1Cleared 510(K)
- K895519SURE & NATURAL(TM) UNSCENTED MENSTRUAL PAD1Cleared 510(K)
- K894229NEW FREEDOM ANYDAY PANTILINERS1Cleared 510(K)
- K893773LAURIER SANITARY NAPKIN1Cleared 510(K)
- K890125SANITARY NAPKIN PADS1Cleared 510(K)
- K891474TAMPAX ULTRAFIT PANTY SHIELDS - MOFIFICATION1Cleared 510(K)
- K890654NEW FREEDOM THIN SUPER & UNSCENTED, MAXI & SUPER1Cleared 510(K)
- K884950TAMPAX ULTRAFIT PANTY SHIELDS1Cleared 510(K)
- K884428ALWAYS UNSCENTED MENSTRUAL PADS1Cleared 510(K)
- K882768LAURIER SANITARY NAPKIN1Cleared 510(K)
- K882364KOTEX LIGHTDAYS LONGS DEODORANT & REG. PANTILINERS1Cleared 510(K)
- K882109DISPOSEABLE MENSTRUAL PANTY1Cleared 510(K)
- K880735UNSCENTED MENSTRUAL PADS1Cleared 510(K)
- K875309SANITARY MENSTRUAL NAPKIN1Cleared 510(K)
- K872481LAURIER NIGHT SAFE EXTRA PROTECTION SANITARY NAP.1Cleared 510(K)
- K872287LADY FREE UNSCENTED MENSTRUAL PAD1Cleared 510(K)
- K871716ULTRA MAXITHINS PADS1Cleared 510(K)
- K871210KOTEX PROFILE SHAPED MAXI PAD1Cleared 510(K)
- K862677MODIFIED MAXITHINS PANTY SHIELDS UNSCENTED1Cleared 510(K)
- K862680MODIFIED REGULAR MAXITHINS PADS, UNSCENTED1Cleared 510(K)
- K862679MODIFIED SUPER MAXITHINS PADS, UNSCENTED1Cleared 510(K)
- K862269LAURIER SANTARY NAPKIN (MODIFICATION)1Cleared 510(K)
- K862271LAURIER SAFETY LONG SANITARY NAPKIN (MODIFICATION)1Cleared 510(K)
- K862270LAURIER OVERNIGHT SANITARY NAPKIN (MODIFICATION)1Cleared 510(K)
- K861902KOTEX PROFILE SHAPED MAXI PAD1Cleared 510(K)
- K861356WHENEVER UNSCENTED SUPER THIN MAXI-PADS1Cleared 510(K)
- K861355WHENEVER UNSCENTED REGULAR THIN MAXI-PADS1Cleared 510(K)
- K861357WHENEVER UNSCENTED PANTY SHIELD1Cleared 510(K)
- K860587KOTEX OVERNITE1Cleared 510(K)
- K860294HOSPITAL TABBED NAPKINS SUPER BELTED FEMININE NAPK1Cleared 510(K)
- K853630BELIEVE HEAVY FLOW PROTECTION LABIAL PADS1Cleared 510(K)
- K852985UNSCENTED ALWAYS PANTILINERS1Cleared 510(K)
- K852924LAURIER SAFETY LONG SANITORY NAPKIN1Cleared 510(K)
- K852922LAURIER OVERNIGHT SANITARY NAPKIN1Cleared 510(K)
- K852226BELIEVE LABIAL PADS1Cleared 510(K)
- K850955ALWAYS MAXIPADS - UNSCENTED1Cleared 510(K)
- K850940ALWAYS SUPER MAXIPAD-UNSCENTED1Cleared 510(K)
- K850034KOTEX THIN MAXI PADS1Cleared 510(K)
- K850033KOTEX MAXI PADS1Cleared 510(K)
- K844602SCENTED MENSTRUAL PAD1Cleared 510(K)
- K844601UNSCENTED MENSTRUAL PAD1Cleared 510(K)
- K844342SURE & NATURAL MAXISHIELDS W/SUPERABSORBENT1Cleared 510(K)
- K844035MENSTRUAL PADS1Cleared 510(K)
- K843401RIA PANTY SHIELDS1Cleared 510(K)
- K843318LAURIER SANITARY NAPKIN1Cleared 510(K)
- K842836SAFE & SOFT MINI PADS & MAXI PADS1Cleared 510(K)
- K842837SAFE & SOFT MAXI SHILEDS1Cleared 510(K)
- K843602BREATHABLE MINI-SHIELD-PRIVATE LABEL1Cleared 510(K)
- K843015SANITARY PANTY W/PADS & DESIGNED1Cleared 510(K)
- K842838SAFE & SOFT PANTY SHIELDS1Cleared 510(K)
- K843061TAMBRANDS INC. ILL.P. 21Cleared 510(K)
- K842950SUPER MAXITHINS BODY-SHAPED MAXI PADS1Cleared 510(K)
- K842951MAXITHINS BODY-SHAPED PANTY SHIELDS1Cleared 510(K)
- K842952REGULAR MAXITHINS BODY-SHAPED MAXI1Cleared 510(K)
- K841311ASSURE-BREATHABLE PANTY LINERS/UNSCENT1Cleared 510(K)
- K842763UNSCENTED MENSTRUAL PAD1Cleared 510(K)
- K842480SURE & NATURAL MAXI-SHIELD1Cleared 510(K)
- K834144UNSCENTED MENSTRUAL PAD1Cleared 510(K)
- K832974MAXITHINS UNSCENTED PANTY SHIELDS1Cleared 510(K)
- K831593MAXI SHIELDS1Cleared 510(K)
- K831707MODIFIED UNSCENTED MENSTRUAL PADS1Cleared 510(K)
- K830224UNSCENTED PANTY SHIELDS1Cleared 510(K)
- K830145PANTY-LINERS UNSCENTED1Cleared 510(K)
- K823477UNSCENTED MENSTRUAL PADS1Cleared 510(K)
- K823241NEW FREEDOM THIN UNSCENTED MAXI PADS1Cleared 510(K)
- K823239SURE & NATURAL MAXISHIELDS1Cleared 510(K)
- K822505OBSTETRICAL KIT1Cleared 510(K)
- K822756U.V.A.C. CURETTES1Cleared 510(K)
- K822242SANITARY/OB NAPKINS1Cleared 510(K)
- K822433GARDS (UNSCENTED, MENSTRUAL PAD)1Cleared 510(K)
- K821800REGULAR MAXITHINS PADS & SUPER MAXITHINS1Cleared 510(K)
- K820960MAXI & MINI SHIELDS1Cleared 510(K)
- K820522CAREFREE PANTY SHIELDS1Cleared 510(K)
- K820288MINI SHIELDS MENSTRUAL PADS1Cleared 510(K)
- K820287MAXI SHIELDS MENSTRUAL PADS1Cleared 510(K)
- K813252UNSCENTED MENSTRUAL PADS-MINI PADS1Cleared 510(K)
- K813251UNSCENTED MENSTRUAL PADS-MAXI PADS1Cleared 510(K)
- K812577UNSCENTED MENSTRUAL PADS1Cleared 510(K)
- K812402UNSCENTED MENSTRUAL PADS1Cleared 510(K)
- K812333CYCLES REUSABLE MENSTRUAL PADS1Cleared 510(K)
- K812232OBSTETRICAL PAD(STEAM STERILIZED)1Cleared 510(K)
- K811869UNSCENTED MENSTRUAL PADS1Cleared 510(K)
- K811766CONFI-DRY ADULT UROABSORBENT PADS1Cleared 510(K)
- K810160TAMPAX MAXITHINS PADS1Cleared 510(K)
- K800952PAPER-PAK OB PADS1Cleared 510(K)
- K800874PELVIC EXAM TRAY1Cleared 510(K)
- K800747BELTLESS MAXI, MINI & SUPER MAXI PADS1Cleared 510(K)
- K800372SANITARY NAPKINS, MAXI 30'S1Cleared 510(K)
- K800185SANITARY NAPKINS MAXI-301Cleared 510(K)
- K792296SANITARY/OB PAD1Cleared 510(K)
- K782112PADS, MINI, MAXI1Cleared 510(K)
- K781470MODESS* BELTLESS FEMININE NAPKIN1Cleared 510(K)
- K770778MAXI-PADS, STAYFREE1Cleared 510(K)
- K760924TUCKS POLYPAD MATERNITY CARE PAD1Cleared 510(K)
- K760455OBSTETRICAL PACK (VIGILON OB PACK)1Cleared 510(K)
- 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
O. B. PACK I
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K902271
- 510(k) Type
- Traditional
- Applicant
- CUSTOMED, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 8/15/1990
- Days to Decision
- 86 days