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
- OTOMesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed2Product Code
- K171271Polyform Synthetic Mesh2Cleared 510(K)
- K150023Vertessa Lite Y-Mesh2Cleared 510(K)
- K150016Vertessa Lite2Cleared 510(K)
- K140116RESTORELLE Y CONTOUR MESH2Cleared 510(K)
- K132061RESTORELLE M, RESTORELLE XL2Cleared 510(K)
- K123028VERTESSA LITE 10 X20CM, VERTESSA LITE 11 X 30CM, VERTESSA LITE Y-MESH2Cleared 510(K)
- K123914RESTORELLE Y CONTOUR2Cleared 510(K)
- K123337VERTESSA LITE 10 X 20CM, VERTESSA LITE 11 X 30CM2Cleared 510(K)
- K122968NOVASILK MESH QTY 1 MODEL 93-6014, NOVASILK MESH QTY 3 MODEL 93-60152Cleared 510(K)
- K122794UPSYLON Y MESH2Cleared 510(K)
- K122440RESTORELLE L2Cleared 510(K)
- K121805AMS LARGE PORE POLYPROPHLENE MESH2Cleared 510(K)
- K113205ARTISYN Y-SHAPED MESH2Cleared 510(K)
- K112322RESTORELLE POLYPROPYLENE Y MESH2Cleared 510(K)
- K120327VERTESSA2Cleared 510(K)
- K101722ALYTE Y-MESH GRAFT2Cleared 510(K)
- K090739BARD SACROCOLPOPEXY GRAFT2Cleared 510(K)
- K053361MODIFICATION TO: MINIMESH POLYPROPYLENE MESH2Cleared 510(K)
- K051485AMS PELVIC FLOOR REPAIR SYSTEM2Cleared 510(K)
- K051245POLYFORM SYNTHETIC MESH2Cleared 510(K)
- K041632MINIMESH POLYPROPYLENE MESH2Cleared 510(K)
- K013718GYNEMESH PROLENE SOFT (POLYPROPYLENE) NONABSORBABLE SYNTHETIC SURGICAL MESH FOR PELVIC FLOOR REPAIR2Cleared 510(K)
- K010931AMS SACRAL COLPOPEXY SLING, MODEL 724035012Cleared 510(K)
- PAJMesh, Surgical, Non-Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed2Product Code
- Subpart E—Obstetrical and Gynecological Surgical DevicesCFR Sub-Part
- 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
RESTORELLE POLYPROPYLENE Y MESH
- Page Type
- Cleared 510(K)
- 510(k) Number
- K112322
- 510(k) Type
- Traditional
- Applicant
- COLOPLAST A/S
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 5/17/2012
- Days to Decision
- 279 days
- Submission Type
- Summary