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
- K041579MEDELA SINGLE USE SILC CUP, MODEL 077.07912Cleared 510(K)
- K043614VACULINK, MODEL VCL 30002Cleared 510(K)
- K021193FORTUNE SILICONE VACUUM SUCTION, MODEL #13002Cleared 510(K)
- K020447MITYVAC MERLIN, MODEL 100272Cleared 510(K)
- K013460SWIFT LOW PROFILE CUP (PRO CUP)2Cleared 510(K)
- K011532MITYVAC2Cleared 510(K)
- K981260KIWI SOFT CUP WITH PALM PUMP MODEL NUMBER VFE-6000S, KIWI MUSHROOM CUP WITH PALM PUMP MODEL VFE-6000M2Cleared 510(K)
- K980976AMEDA DISPOSABLE VACUUM ASSIST CUP WITH FLUID RETENTION TRAP2Cleared 510(K)
- K980212MITYVAC2Cleared 510(K)
- K973942SWIFT DELIVERY PRODUCT #3002Cleared 510(K)
- K970170SWIFT DELIVERY PRODUCT #002-VAC EX CUP W/VAC REL VALVE2Cleared 510(K)
- K963287VACUUM CUP (004SD)2Cleared 510(K)
- K960549MITYVAC DIRECTIONAL VACUUM EXTRACTOR, DISPOSABLE2Cleared 510(K)
- K942725CMI VELVET TOUCH VACUUM EXTRACTOR2Cleared 510(K)
- K943938MITYVAC SUPER M STYLE VACUM EXTRACTOR, DISPOSABLE2Cleared 510(K)
- K934011MITYVAC(R) OBSTETRIC VAC DELIV KIT W/UNIV VAC RELEASE2Cleared 510(K)
- K913324MITYVAC(R) SAFTISOFT OBSTETRICAL VACUUM DELIV KIT2Cleared 510(K)
- K915763MODIFIED DISPOSABLE FETAL VACUUM2Cleared 510(K)
- K911326OBSTETRICAL VACUUM CUP2Cleared 510(K)
- K895700AMEDA/EGNELL DOLPHIN DISPO-SOFT VACUUM EXTRACTOR2Cleared 510(K)
- K895446CMI VACUUM PUMP W/#101A VACUUM PUMP (AUTO-CLAVE.)2Cleared 510(K)
- K891465OBSTETRIC CUP (MODIFICATION)2Cleared 510(K)
- K890307MITYVAC M STYLE VACUUM EXTRACTOR, DISPOSABLE2Cleared 510(K)
- K881967CMI VACUUM PUMP #001C - VACUUM PUMP (NON-ELECTRI.)2Cleared 510(K)
- K881306CMI VACUUM DELIVERY SYSTEM #003C AND #004C2Cleared 510(K)
- K841492AB VACUUM EXTRACTOR SILC-CUP2Cleared 510(K)
- K840008O'NEIL OBSTETRIC CUP2Cleared 510(K)
- K830012MEDELA SUCTION PUMP2Cleared 510(K)
- K771558SILASTIC BRAND OBSTETRICAL VACUUM CUP2Cleared 510(K)
- 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
- 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
CMI VACUUM DELIVERY SYSTEM #003C AND #004C
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K881306
- 510(k) Type
- Traditional
- Applicant
- CHALLENGE MFG., INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 6/13/1988
- Days to Decision
- 77 days