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
- K041332JOEY CLAMP OPENING TOOL2Cleared 510(K)
- K033846KAEN YIH UMBILICAL CORD CLAMP2Cleared 510(K)
- K020718SECURLINE UMBILICAL CORD CLAMP #3505 STERILE #3515 NON-STERILE2Cleared 510(K)
- K021055BUSSE UMBILICAL CORD CLAMP CUTTER2Cleared 510(K)
- K012917DYNAREX UMBILICAL CORD LAMP, MODELS 6833 AND 6833-B2Cleared 510(K)
- K011621KOALA CLAMP, KOALA CLAMP AND CUTTER2Cleared 510(K)
- K010695KOALA CLAMP2Cleared 510(K)
- K010835POSI-GRIP UMBILICAL CORD CLAMP, STERILE, MODEL 384, POSI-GRIP UMBILICAL CORD CLAMP, NON-STERILE, MODEL 3852Cleared 510(K)
- K000227UMBICUT2Cleared 510(K)
- K994367UMBILICAL CORD CLAMP2Cleared 510(K)
- K994263SECURLINE UMBILICAL CORD CLAMP CLIPPER #35402Cleared 510(K)
- K990737'ECURLINE UMBILICAL CORD CLAMP #35002Cleared 510(K)
- K983204HARWILL MEDICAL U-KLIP UMBILICAL CLAMP2Cleared 510(K)
- K974227HOSPITAL'S CLAMP2Cleared 510(K)
- K963223EZ-CIRC2Cleared 510(K)
- K963889QFC UMBILICAL CLAMP2Cleared 510(K)
- K963428UMBILICAL CLAMP AND CUTTER2Cleared 510(K)
- K945841BIRTH THEFT INFANT IDENTIFICATION AND PROTECTION UMBILICAL CORD CLAMP2Cleared 510(K)
- K951140KORDKLAMP UMBILICAL CORD CLAMP APPLICATOR2Cleared 510(K)
- K933763SAVE-T-BREATH AMBILICAL CORD CLAMP2Cleared 510(K)
- K934525AUTO SUTURE DISPOSABLE UMBILICAL CLIP APPLIER2Cleared 510(K)
- K923439LUNEAU UMBILICAL CORD CLAMP2Cleared 510(K)
- K912419CORDGUARD BLOOD COLLECTION DEVICE2Cleared 510(K)
- K915569UMBILICAL CLAMP2Cleared 510(K)
- K912054LABOR DELIVERY TRAY2Cleared 510(K)
- K912869WOMEN AND INFANT'S DELIVERY PACK2Cleared 510(K)
- K901954AMEDA/EGNELL DOLPHIN UMBILICAL CORD SEVERING DEVIC2Cleared 510(K)
- K901557UMBILICAL CORD CLAMP AND CUTTER2Cleared 510(K)
- K894646#556 DISPOSABLE UMBILICAL CORD CLAMP (2)2Cleared 510(K)
- K890382COMPRESSION FORCEPS2Cleared 510(K)
- K880753UMBILICAL CORD CLAMP2Cleared 510(K)
- K871075SCMT UMBILICAL CLAMP2Cleared 510(K)
- K870446DOLPHIN UMBILICAL CORD CLAMP2Cleared 510(K)
- K863645SCHULMAN DOUBLE UMBILICAL CORD CLAMP NO. 10002Cleared 510(K)
- K860445CLAMP-N-CUT2Cleared 510(K)
- K781548UMBILICAL CORD CLAMP2Cleared 510(K)
- 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
- 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
WOMEN AND INFANT'S DELIVERY PACK
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K912869
- 510(k) Type
- Traditional
- Applicant
- WELCON, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 12/4/1991
- Days to Decision
- 159 days
- Submission Type
- Statement