FDA Product Code
FDA Product Code OTO — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- General, Plastic Surgery
- 21 CFR Citation
- 878.3300
510(k) Clearances — 23 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K171271 | Polyform Synthetic Mesh | Boston Scientific Corporation | 2017-12-15 | Special | PDF ↗ |
| K150016 | Vertessa Lite | Caldera Medical, Inc. | 2015-04-06 | Traditional | PDF ↗ |
| K150023 | Vertessa Lite Y-Mesh | Caldera Medical, Inc. | 2015-04-06 | Traditional | PDF ↗ |
| K140116 | RESTORELLE Y CONTOUR MESH | Coloplast A/S | 2014-02-12 | Special | PDF ↗ |
| K132061 | RESTORELLE M, RESTORELLE XL | Coloplast Corp. | 2013-08-02 | Special | PDF ↗ |
| K123028 | VERTESSA LITE 10 X20CM, VERTESSA LITE 11 X 30CM, VERTESSA LITE Y-MESH | Caldera Medical, Inc. | 2013-04-25 | Traditional | PDF ↗ |
| K123914 | RESTORELLE Y CONTOUR | Coloplast A/S | 2013-03-05 | Special | PDF ↗ |
| K123337 | VERTESSA LITE 10 X 20CM, VERTESSA LITE 11 X 30CM | Caldera Medical | 2013-02-21 | Traditional | PDF ↗ |
| K122794 | UPSYLON Y MESH | Boston Scientific Corp | 2012-12-18 | Traditional | PDF ↗ |
| K122968 | NOVASILK MESH QTY 1 MODEL 93-6014, NOVASILK MESH QTY 3 MODEL 93-6015 | Coloplast Corp. | 2012-12-18 | Traditional | PDF ↗ |
| K122440 | RESTORELLE L | Coloplast Corp. | 2012-11-19 | Traditional | PDF ↗ |
| K121805 | AMS LARGE PORE POLYPROPHLENE MESH | American Medical Systems | 2012-10-16 | Traditional | PDF ↗ |
| K113205 | ARTISYN Y-SHAPED MESH | ETHICON, Inc. | 2012-06-11 | Traditional | PDF ↗ |
| K112322 | RESTORELLE POLYPROPYLENE Y MESH | Coloplast A/S | 2012-05-17 | Traditional | PDF ↗ |
| K120327 | VERTESSA | Caldera Medical, Inc. | 2012-05-10 | Traditional | PDF ↗ |
| K101722 | ALYTE Y-MESH GRAFT | C.R. Bard, Inc. | 2011-04-01 | Traditional | PDF ↗ |
| K090739 | BARD SACROCOLPOPEXY GRAFT | C.R. Bard, Inc. | 2009-11-10 | Traditional | PDF ↗ |
| K053361 | MODIFICATION TO: MINIMESH POLYPROPYLENE MESH | Mpathy Medical Devices, Ltd. | 2006-02-06 | Special | PDF ↗ |
| K051485 | AMS PELVIC FLOOR REPAIR SYSTEM | American Medical Systems, Inc. | 2005-08-03 | Traditional | PDF ↗ |
| K051245 | POLYFORM SYNTHETIC MESH | Proxy Biomedical , Ltd. | 2005-06-17 | Traditional | PDF ↗ |
| K041632 | MINIMESH POLYPROPYLENE MESH | Mpathy Medical Devices, Ltd. | 2004-11-17 | Traditional | PDF ↗ |
| K013718 | GYNEMESH PROLENE SOFT (POLYPROPYLENE) NONABSORBABLE SYNTHETIC SURGICAL MESH FOR PELVIC FLOOR REPAIR | Gynecare, A Div. of Ethicon, Inc. | 2002-01-08 | Traditional | PDF ↗ |
| K010931 | AMS SACRAL COLPOPEXY SLING, MODEL 72403501 | American Medical Systems, Inc. | 2001-04-09 | Special | PDF ↗ |
Product code OTO · Class II · General, Plastic Surgery. Data: openFDA.