FDA Product Code
FDA Product Code FTL — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- General, Plastic Surgery
- 21 CFR Citation
- 878.3300
510(k) Clearances — 337 records · page 4 of 4
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K960481 | SOFT TISSUE AUGMENTATION TUBE | Tissue Technologies, Inc. | 1996-04-01 | Traditional | PDF ↗ |
| K960219 | PROLEX MESH | Advanced Surgical Innovations, Inc. | 1996-03-15 | Traditional | PDF ↗ |
| K954665 | GLYCAR STAPLE STRIPS | Glycar, Inc. | 1996-02-14 | Traditional | PDF ↗ |
| K955494 | GORE-TEX DUALMESH BIOMATERIAL WITH HOLES | W. L. Gore & Associates, Inc. | 1996-01-24 | Traditional | PDF ↗ |
| K952898 | GORE-TEX SAM FACIAL IMPLANT WITH INTRODUCER | W. L. Gore & Associates, Inc. | 1995-11-14 | Traditional | PDF ↗ |
| K951676 | GORE-TEX DUALMESH BIOMATERIAL | W. L. Gore & Associates, Inc. | 1995-10-07 | Traditional | PDF ↗ |
| K951700 | GORE-TEX SOFT TISSUE PATCH | W. L. Gore & Associates, Inc. | 1995-10-07 | Traditional | PDF ↗ |
| K951675 | GORE-TEX MYCROMESH BIOMATERIAL | W. L. Gore & Associates, Inc. | 1995-10-07 | Traditional | PDF ↗ |
| K953577 | BARD VISILEX MESH 3 X 6 | Davol Inc., Sub. C. R. Bard, Inc. | 1995-09-26 | Traditional | PDF ↗ |
| K946106 | GORE-TEX DUALMESH PLUS BIOMATERIAL | W. L. Gore & Associates, Inc. | 1995-04-24 | Traditional | PDF ↗ |
| K946107 | GORE-TEX MYCROMESH PLUS BIOMATERIAL | W. L. Gore & Associates, Inc. | 1995-04-24 | Traditional | PDF ↗ |
| K945060 | HERNIA MESH INTRODUCTION SYSTEM | Gerard Medical, Inc. | 1995-03-02 | Traditional | PDF ↗ |
| K945899 | GORE-TEX(R) CURVED SURGICALMEMBRANE | W. L. Gore & Associates, Inc. | 1995-02-13 | Traditional | PDF ↗ |
| K942911 | GLYCAR TISSUE REPAIR PATCH | Glycar, Inc. | 1994-12-14 | Traditional | PDF ↗ |
| K945377 | TRELEX NATURAL(R) MESH | Meadox Medicals, Div. Boston Scientific Corp. | 1994-12-08 | Traditional | PDF ↗ |
| K944413 | ACM PTFE SURGICAL MESH | American Custom Medical, Inc. | 1994-11-09 | Traditional | PDF ↗ |
| K922452 | GORE-TEX SOFT TISSUE PATCH PLUS | W. L. Gore & Associates, Inc. | 1994-09-29 | Traditional | PDF ↗ |
| K941299 | FLARED PATCH | Flared Patch, Inc. | 1994-08-23 | Traditional | PDF ↗ |
| K942583 | PERI-STRIPS PLANAR CONFIGURATION STAPLE LINE REINFORCEMENT | Bio-Vascular, Inc. | 1994-07-08 | Traditional | PDF ↗ |
| K933827 | BIOSIL MEDICAL GRADE SILICONE SHEETING FOR OBSTETRICAL & GYNOCOLOGY APPLICATIONS | Bioplexus Corp. | 1994-06-30 | Traditional | PDF ↗ |
| K930822 | GORE-TEX SOFT TISSUE PATCH,SURGICAL MEMBRANE,MESH | W. L. Gore & Associates, Inc. | 1994-01-28 | Traditional | PDF ↗ |
| K931936 | GIANTURCO-HELFRICH HERNIS MESH | Cook, Inc. | 1994-01-10 | Traditional | PDF ↗ |
| K930669 | ATRIUM POLYPROPYLENE MESH | Atrium Medical Corp. | 1993-12-16 | Traditional | PDF ↗ |
| K926478 | GORE-TEK(R) SOFT TISSUE PATCH | W. L. Gore & Associates, Inc. | 1993-11-29 | Traditional | PDF ↗ |
| K931150 | GORE-TEX MICRO MESH | W. L. Gore & Associates, Inc. | 1993-10-29 | Traditional | PDF ↗ |
| K926565 | GORE-TEX(TM) DUAL MESH | W. L. Gore & Associates, Inc. | 1993-09-09 | Traditional | PDF ↗ |
| K925148 | AUTO SUTURE SURGICAL MESH DEPLOYER | United States Surgical, A Division of Tyco Healthc | 1993-02-12 | Traditional | PDF ↗ |
| K924749 | TRELEX MESH | Meadox Medicals, Div. Boston Scientific Corp. | 1992-11-23 | Traditional | PDF ↗ |
| K922916 | BARD MARLEX MESH DART | C.R. Bard, Inc. | 1992-08-24 | Traditional | PDF ↗ |
| K915526 | COATED SURGIPRO(TM) POLYPROPYLENE SURGICAL MESH | United States Surgical, A Division of Tyco Healthc | 1992-05-29 | Traditional | PDF ↗ |
| K914449 | GORE-TEX(R) SOFT TISSUE PATCH, PROCESS CHANGE | W. L. Gore & Associates, Inc. | 1991-12-04 | Traditional | PDF ↗ |
| K905655 | NONABSORBABLE POLYPROPYLENE SURGICAL MESH | United States Surgical, A Division of Tyco Healthc | 1990-12-31 | Traditional | PDF ↗ |
| K840172 | VENTRAL WALL DEFECT REDUCT SILO | American Heyer Schulte | 1984-06-27 | Traditional | PDF ↗ |
| K833764 | STERILIZATION OF GORE-TEX SOFT TISSU | W. L. Gore & Associates, Inc. | 1984-01-10 | Traditional | PDF ↗ |
| K820193 | GORE-TEX TISSUE REINFORCEMENT PATCH | W. L. Gore & Associates, Inc. | 1982-03-26 | Traditional | PDF ↗ |
| K810428 | VICRYL | ETHICON, Inc. | 1981-03-13 | Traditional | PDF ↗ |
| K792281 | USHER'S MARLEX TUBULAR MESH | Davol, Inc. | 1979-11-27 | Traditional | PDF ↗ |
Product code FTL · Class II · General, Plastic Surgery. Data: openFDA.