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
- HERPelvimeter, External1Product Code
- FHGBell, Circumcision2Product Code
- FHJShield, Circumcision2Product Code
- HCYCurette, Uterine1Product Code
- HCZForceps, Surgical, Gynecological2Product Code
- HDAForceps, Obstetrical2Product Code
- HDBExtractor, Vacuum, Fetal2Product Code
- HDCTenaculum, Uterine2Product Code
- HDDTable, Obstetrical, Ac-Powered (And Accessories)2Product Code
- HDEHook, Fibroid, Gynecological1Product Code
- HDFSpeculum, Vaginal, Metal1Product Code
- HDGSpeculum, Vaginal, Metal, Fiberoptic1Product Code
- HDHNeedle, Cerclage, Gynecological1Product Code
- HDIHook, Destructive, Obstetrical2Product Code
- HDJScissors, Umbilical1Product Code
- HDKScissors, Episiotomy1Product Code
- HDLRetractor, Vaginal1Product Code
- HDMPacker, Uterine1Product Code
- HDNDilator, Cervical, Expandable3Product Code
- HDPElevator, Uterine2Product Code
- HDQDilator, Cervical, Fixed Size1Product Code
- HDYDilator, Cervical, Hygroscopic-Laminaria2Product Code
- HDZKnife, Cervical Cone2Product Code
- HFBForceps, Biopsy, Gynecological1Product Code
- HFGCoagulator, Laparoscopic, Unipolar (And Accessories)2Product Code
- HFHCoagulator, Hysteroscopic (And Accessories)2Product Code
- HFICoagulator, Culdoscopic (And Accessories)2Product Code
- HFWClamp, Umbilical2Product Code
- HFXClamp, Circumcision2Product Code
- HFZCraniotribe2Product Code
- HGACranioclast2Product Code
- HGCClamp, Uterine1Product Code
- HGDApplicator, Vaginal1Product Code
- HGEAmniotome1Product Code
- HGIElectrocautery, Gynecologic (And Accessories)2Product Code
- HHFRemover, Intrauterine Device, Contraceptive, Hook-Type1Product Code
- HHGDilator, Cervical, Vibratory3Product Code
- HHMSound, Uterine1Product Code
- HHNCleidoclast2Product Code
- HHOScrew, Fibroid, Gynecological2Product Code
- HHPTable, Obstetrical, Manual (And Accessories)2Product Code
- HHRLaser, Surgical, Gynecologic2Product Code
- HHTSpatula, Cervical, Cytological2Product Code
- HIBSpeculum, Vaginal, Nonmetal2Product Code
- HICSpeculum, Vaginal, Nonmetal, Fiberoptic2Product Code
- HIMElectrocautery, Endoscopic And Accessories2Product Code
- HINCoagulator-Cutter, Endoscopic, Bipolar (And Accessories)2Product Code
- KNAInstrument, Manual, Specialized Obstetric-Gynecologic2Product Code
- K130087PANPAC WORD/BARTHOLIN CATHETER2Cleared 510(K)
- K102141COOK WORD BARTHOLIN GLAND CATHETER (FINAL TRADE NAME NOT YET DETERMINED)2Cleared 510(K)
- K093904GLENVEIGH VAGINAL TAMPONADE BALLOON CATHETER2Cleared 510(K)
- K082939COOK FETAL MEMBRANE MANIPULATOR, MODEL -FMM-1224002Cleared 510(K)
- K062438BAKRI POSTPARTUM BALLOON, MODEL J-SOS-1005002Cleared 510(K)
- K060289EPISTAT, V-STAT, MODELS EPISTAT-001-01, V-STAT-001-012Cleared 510(K)
- K013597TAMPONADE UTERINE BALLOON CATHETER SET2Cleared 510(K)
- K014248DND 202 MANUAL UROLOGICAL DIGITAL NEEDLE DRIVER2Cleared 510(K)
- K001590DND 1012Cleared 510(K)
- K990738DR. JAHANGER'S CUTTER2Cleared 510(K)
- K990045BERACLAMP, MODEL BC-12Cleared 510(K)
- K982464SCC-23 SAFETY CLAMP AND CUTTER2Cleared 510(K)
- K980717UROMED SLING KIT2Cleared 510(K)
- K980237GYNEX ENDOSPECULUM2Cleared 510(K)
- K972013NATIONAL MEDICAL HEALTHCARE CUSTOM OB/GYN KITS, TRAYS, OR PACKS2Cleared 510(K)
- K971277SAFE-T-CLAMP2Cleared 510(K)
- K952527BALLOON UTERINE STENT2Cleared 510(K)
- K954619CORDGUARD II2Cleared 510(K)
- K951081OB/GYN PACKS2Cleared 510(K)
- K940907MADDEN SURGICAL THIMBLE2Cleared 510(K)
- K941641DISPOSABLE EMERGENCY OBSTETRICAL KIT2Cleared 510(K)
- K926532ENDO CERVICAL CURETTE2Cleared 510(K)
- K930727VARIOUS SCISSORS2Cleared 510(K)
- K930110MICRO SURGERY NEEDLE HOLDERS2Cleared 510(K)
- K930031MICRO SURGERY SCISSORS2Cleared 510(K)
- K926530MIYA HOOK2Cleared 510(K)
- K926537NEEDLE EXTENSIONS2Cleared 510(K)
- K926529Z CLAMP SCISSORS2Cleared 510(K)
- K930032RETRACTOR RODS2Cleared 510(K)
- K912075C-SECTION TRAY2Cleared 510(K)
- K891398RETRACTOR RODS2Cleared 510(K)
- K891399CORSON MYOMA GRASPING FORCEPS2Cleared 510(K)
- K891397GREENE-ARMYTAGE HEMOSTATIC FORCEPS2Cleared 510(K)
- K891046SOPHER AND BIERER OVUM FORCEPS2Cleared 510(K)
- K891045MIYA HOOK2Cleared 510(K)
- K891048OVUM FORCEPS-BARRET,JAVERTS,WILLET,HANSEN,COREY,MC2Cleared 510(K)
- K891039MICRO SURGERY FORCEPS2Cleared 510(K)
- K891040MICRO SURGERY SCISSORS2Cleared 510(K)
- K891042MICRO SURGERY NEEDLE HOLDERS2Cleared 510(K)
- K884291COOK HYSTEROCATH(TM)2Cleared 510(K)
- K880497WORD BARTHOLIN GLAND CATHETER CODE: 10052Cleared 510(K)
- K863439INTRAUTERINE HEMOSTASIS BALLOON STENT2Cleared 510(K)
- K871069MODIFIED HYSTEROSALPINGOGRAPY SET2Cleared 510(K)
- K864623OBSTETRICAL/GYNECOLOGICAL CUSTOM SURGICAL KIT2Cleared 510(K)
- K861385MILEX BARTHOLIN GLAND CATHETER2Cleared 510(K)
- K844821MICROINFERTILITY NEEDLE HOLDER, TITANIUM2Cleared 510(K)
- K844822MICROINFERTILITY SCISSORS, TITANIUM2Cleared 510(K)
- K844823MICROINFERTILITY FORCEPS, TITANIUM2Cleared 510(K)
- K842231ACKRAD HYSTEROSALPINGOGRAPHY SET2Cleared 510(K)
- K810483FALLOPIAN TUBE FORCEPS2Cleared 510(K)
- K810484OVARY FORCEPS2Cleared 510(K)
- K792631STERILIZATION PROCESS/DBL. GRIP CORD CLP2Cleared 510(K)
- K790853EASY-SPEC2Cleared 510(K)
- K790852VAGI-SPEC2Cleared 510(K)
- K790923MI-MARK ENDOCERVICAL SAMPLING SET2Cleared 510(K)
- K780587GYNESURG2Cleared 510(K)
- K770641MINI-CONER TM2Cleared 510(K)
- K770727MANIPULATOR & INJECTOR, UTERINE2Cleared 510(K)
- KNBInstrument, Destructive, Fetal, Obstetric2Product Code
- KNCTable, Obstetric (And Accessories)2Product Code
- KNFCoagulator-Cutter, Endoscopic, Unipolar (And Accessories)2Product Code
- KOHInstrument, Manual, General Obstetric-Gynecologic1Product Code
- LBXPelvimeter, Internal2Product Code
- LKFCannula, Manipulator/Injector, Uterine2Product Code
- LLWLaser, Neodymium:Yag For Gynecologic Use2Product Code
- MDGSystem, Intrafallopian Cannula2Product Code
- MLSLabor And Delivery Kit2Product Code
- MLTPelvic Exam Kit2Product Code
- MOVCatheters, Salpingography2Product Code
- MPUSource, Chemiluminescent Light2Product Code
- NBZClamp And Cutter, Umbilical2Product Code
- NMGForceps, Biopsy, Gynecological, Reprocessed2Product Code
- OHCObstetrical Vacuum Delivery Kit2Product Code
- PBQFixation, Non-Absorbable Or Absorbable, For Pelvic Use2Product Code
- OHGCircumcision Tray2Product Code
- PFJCatheter, Balloon, Dilation Of Cervical Canal Prior To Labor2Product Code
- OHLPap Smear Kit2Product Code
- OJFHysterectomy Kit2Product Code
- PGKCannula, Injector, Uterine, Endometrial Biopsy2Product Code
- PKNDilator, Cervical, Synthetic, Osmotic2Product Code
- OKUEmergency Obstetrical Kit1Product Code
- OKVObstetrical Kit2Product Code
- OKYCytology Kit2Product Code
- OQYIntrauterine Tamponade Balloon2Product Code
- PMUContainment System, Laparoscopic Power Morcellation, With Instrument Port2Product Code
- PONCatheter, Balloon, Dilation Of Cervical Canal2Product Code
- PUATenaculum, Uterine, Exempt2Product Code
- PVRD&C Tray2Product Code
- PVXVaginal Examination Tray2Product Code
- PWBFetal Head Elevator2Product Code
- PWIInstrumentation, Surgical Mesh, Urogynecologic, Transvaginal Repair Of Pelvic Organ Prolapse2Product Code
- PWKInstrumentation, Surgical Mesh, Urogynecologic, Transabdominal Repair Of Pelvic Organ Prolapse2Product Code
- Subpart F—Obstetrical and Gynecological Therapeutic DevicesCFR Sub-Part
- 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
OB/GYN PACKS
- Page Type
- Cleared 510(K)
- 510(k) Number
- K951081
- 510(k) Type
- Traditional
- Applicant
- STERILE CONCEPTS, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 11/13/1995
- Days to Decision
- 249 days
- Submission Type
- Summary