FDA Product Code
FDA Product Code OTP — Clearance Directory
- Device Class
- Class III
- Assigned Panel
- Obstetrics/Gynecology
- 21 CFR Citation
- 884.5980
510(k) Clearances — 31 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K122459 | PINNACLE LITE PELVIC FLOOR REPAIR KIT, POSTERIOR UPHOLD LITE VAGINAL SUPPORT SYSTEM | Boston Scientific Corporation | 2012-12-13 | Abbreviated | PDF ↗ |
| K121612 | ELEVATE PROLAPSE REPAIR SYSTEMS-APICAL NEEDLE PASSER SHEATH MODIFICATION | American Medical Systems | 2012-07-20 | Special | PDF ↗ |
| K112842 | AMS ELEVATE PC | American Medical Systems, Inc. | 2011-10-25 | Special | PDF ↗ |
| K103426 | LITE PELVIC FLOOR REPAIR KITS | Boston Scientific Corp | 2011-09-14 | Abbreviated | PDF ↗ |
| K112386 | EXAIR ANTERIOR AND POSTERIOR PROLAPSE REPAIR SYSTEM | Coloplast Corp. | 2011-09-08 | Special | PDF ↗ |
| K102815 | SURELIFT PROLAPSE SYSTEM | Neomedic International | 2011-07-07 | Traditional | PDF ↗ |
| K111118 | AMS ELEVATE PC APICAL AND POSTERIOR ( AND ANTERIOR AND APICAL) PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE | American Medical Systems | 2011-07-01 | Special | PDF ↗ |
| K092207 | RESTORELLE POLYPROPYLENE MESH | Mpathy Medical Devices, Inc. | 2009-08-04 | Special | PDF ↗ |
| K083499 | EXAIR ANTERIOR AND POSTERIOR PROLAPSE REPAIR SYSTEMS | Coloplast A/S | 2009-05-08 | Traditional | PDF ↗ |
| K091131 | PELVIC FLOOR REPAIR SYSTEM | Boston Scientific | 2009-05-08 | Abbreviated | PDF ↗ |
| K090713 | ELEVATE PROLAPSE REPAIR SYSTEM WITH PC COATED INTEPRO LITE- APICAL AND POSTERIOR PROLAPSE REPAIR SYSTEM, ANTERIOR AND AP | American Medical Systems, Inc. | 2009-04-02 | Special | PDF ↗ |
| K083722 | ASCEND | Caldera Medical, Inc. | 2009-03-31 | Traditional | PDF ↗ |
| K083839 | AVAULTA SOLO SYNTHETIC SUPPORT SYSTEM, AVAULTA PLUS BIOSYNTHETIC SUPPORT SYSTEM | C.R. Bard, Inc. | 2009-01-15 | Special | PDF ↗ |
| K082677 | AMS ELEVATE ANTERIOR & APICAL PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE | American Medical Systems, Inc. | 2008-12-23 | Special | PDF ↗ |
| K082387 | APOGEE AND PERIGEE SYSTEMS WITH INTEPRO LITE AND INTEXEN LP, PART OF THE AMS; PELVIC FLOOR REPAIR SYSTEM | American Medical Systems | 2008-12-04 | Special | PDF ↗ |
| K082730 | AMS ELEVATE APICAL AND POSTERIOR PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE, AMS ELEVATE APICAL AND POSTERIOR PROLAPSE | American Medical Systems, Inc. | 2008-11-26 | Special | PDF ↗ |
| K081710 | APOGEE AND PERIGEE SYSTEMS WITH PC COATED INTEPRO LITE | American Medical Systems | 2008-10-15 | Traditional | PDF ↗ |
| K082571 | AVAULTA SUPPORT SYSTEM | C.R. Bard, Inc. | 2008-09-30 | Special | PDF ↗ |
| K081048 | PINNACLE PELVIC FLOOR REPAIR KIT II | Boston Scientific Corp | 2008-08-22 | Abbreviated | PDF ↗ |
| K071512 | GYNECARE PROLIFT +M* PELVIC FLOOR REPAIR SYSTEMS | ETHICON, Inc. | 2008-05-15 | Traditional | PDF ↗ |
| K080185 | AMS ELEVATE WITH INTEPRO LITE PROLAPSE REPAIR SYSTEM, AMS ELEVATE WITH INTEXEN LP PROLAPSE REPAIR SYSTEM | American Medical Systems, Inc. | 2008-04-10 | Special | PDF ↗ |
| K072951 | PARIETENE DUO AND QUADRA POLYPROPYLENE MESHES | Sofradim Production | 2007-12-19 | Special | PDF ↗ |
| K071957 | PINNACLE PELVIC FLOOR REPAIR KITS | Boston Scientific Corp | 2007-11-08 | Abbreviated | PDF ↗ |
| K063712 | AVAULTA SUPPORT SYSTEM/AVAULTA PLUS BIOSYNTHETIC SUPPORT SYSTEM | C.R. Bard, Inc. | 2007-03-12 | Traditional | PDF ↗ |
| K063562 | GYNECARE PROSIMA PELVIC FLOOR REPAIR SYSTEMS | ETHICON, Inc. | 2007-02-26 | Traditional | PDF ↗ |
| K053414 | MENTOR NOVASILK MESH | Mentor Corp. | 2005-12-27 | Traditional | PDF ↗ |
| K051503 | UGYTEX SUAL KNIT MESH | Sofradim Production | 2005-08-05 | Traditional | PDF ↗ |
| K040623 | AMS PERIGEE SYSTEM | American Medical Systems, Inc. | 2004-05-17 | Traditional | PDF ↗ |
| K040537 | AMS APOGEE VAULT SUSPENSION SYSTEM | American Medical Systems, Inc. | 2004-04-22 | Traditional | PDF ↗ |
| K040521 | MODIFICATION TO AMS LARGE PORE POLYPROPYLENE MESH | American Medical Systems, Inc. | 2004-03-24 | Special | PDF ↗ |
| K033636 | AMS LARGE PORE POLYPROPYLENE MESH | American Medical Systems, Inc. | 2003-12-31 | Traditional | PDF ↗ |
Product code OTP · Class III · Obstetrics/Gynecology. Data: openFDA.