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 3 of 4
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K060004 | CALDERA MESH | Caldera Medical, Inc. | 2006-02-22 | Traditional | PDF ↗ |
| K053424 | POPMESH | Caldera Medical, Inc. | 2006-02-22 | Traditional | PDF ↗ |
| K052830 | SPORTMESH | Artimplant AB | 2006-01-19 | Traditional | PDF ↗ |
| K053158 | OPTILENE MESH LP | Aesculap, Inc. | 2006-01-18 | Traditional | PDF ↗ |
| K052864 | TYRX SURGICAL MESH, MODEL SMPC-0501 | Tyrx Pharma, Inc. | 2005-12-22 | Traditional | PDF ↗ |
| K053066 | SEPRAMESH IP BIORESORBABLE COATING/PERMANENT MESH | Genzyme Corporation | 2005-12-19 | Traditional | PDF ↗ |
| K053202 | GORE SEAMGUARD BIOABSORBABLE STAPLE LINE REINFORCEMENT MATERIAL | W.L. Gore & Associates | 2005-12-07 | Special | PDF ↗ |
| K053200 | GORE SEAMGUARD STAPLE LINE REINFORCEMENT MATERIAL | W. L. Gore & Associates, Inc. | 2005-12-07 | Special | PDF ↗ |
| K052155 | BARD LARGE PORE SOFT MESH AND SOFT MESH PRESHAPED | C.R. Bard, Inc. | 2005-10-20 | Traditional | PDF ↗ |
| K051701 | VICRYL * MESH BAG | ETHICON, Inc. | 2005-09-29 | Traditional | PDF ↗ |
| K050969 | INCLOSE SURGICAL MESH SYSTEM | Anulex Technologies, Inc. | 2005-08-18 | Traditional | PDF ↗ |
| K052100 | MODIFICATION TO MOTIFMESH SOFT TISSUE PATCH | Proxy Biomedical , Ltd. | 2005-08-11 | Special | PDF ↗ |
| K051766 | ORTHOMEND | Tei Biosciences, Inc. | 2005-08-11 | Abbreviated | PDF ↗ |
| K050332 | SURGI-WRAP MAST BIORESORBABLE SHEET | Mast Biosurgery USA, Inc. | 2005-05-27 | Traditional | PDF ↗ |
| K050678 | MOTIFMESH SOFT TISSUE PATCH | Proxy Biomedical , Ltd. | 2005-05-20 | Traditional | PDF ↗ |
| K050418 | TISSUE FIXATION SYSTEM | Tfs Manufacturing Pty, Ltd. | 2005-05-16 | Traditional | PDF ↗ |
| K043191 | REPOL ANGIMESH, ANGIMESH PRE, FOLDED MESH, REPOL PLUG BASIC, REPOL PLUG CAP, REPOL PLUG FLOWER AND WINGS MESH | Angiologica B. M. Srl | 2005-05-16 | Traditional | PDF ↗ |
| K050187 | PARIETEX COMPOSITE PCO-OS AND PCO-OB MESHES | Sofradim Production | 2005-02-18 | Special | PDF ↗ |
| K043081 | GORE POLYPROPYLENE HERNIA MESH | W. L. Gore & Associates, Inc. | 2004-12-22 | Traditional | PDF ↗ |
| K043056 | GORE SEAMGUARD BIOABSORBABLE STAPLE LINE REINFORCEMENT MATERIAL | W. L. Gore & Associates, Inc. | 2004-12-22 | Traditional | PDF ↗ |
| K043366 | PERMACOL SURGICAL IMPLANT | Tissue Science Laboratories, Plc | 2004-12-17 | Traditional | PDF ↗ |
| K042811 | VIVOSORB SHEET, MODEL FS01 | Polyganics B.V., | 2004-11-08 | Traditional | PDF ↗ |
| K042026 | BARD CK PARASTOMAL HERNIA PATCH, MODELS 0118001, 0118002, 0118003, 0118004 | C.R. Bard, Inc. | 2004-09-10 | Traditional | PDF ↗ |
| K040998 | MODIFICATION TO PARIETEX COMPOSITE (PCO) MESH | Sofradim Production | 2004-04-29 | Special | PDF ↗ |
| K033337 | ULTRAPRO MESH | ETHICON, Inc. | 2004-04-01 | Traditional | PDF ↗ |
| K033814 | BARD SOFT MESH, MODELS 0117001, 0117002, 0117003, 0117004, 0117005, 0117006, 0117007 | C.R. Bard, Inc. | 2004-03-01 | Traditional | PDF ↗ |
| K033376 | UGYTEX MESH | Sofradim Production | 2004-01-15 | Traditional | PDF ↗ |
| K032893 | SHELHIGH NO-REACT BIOCUFF | Shelhigh, Inc. | 2003-12-19 | Traditional | PDF ↗ |
| K032865 | GORE SEAMGUARD BIOABSORBABLE STAPLE LINE REINFORCEMENT MATERIAL | W. L. Gore & Associates, Inc. | 2003-11-28 | Traditional | PDF ↗ |
| K032673 | IMMIX PLASTIFILM | Osteobiologics, Inc. | 2003-10-02 | Special | PDF ↗ |
| K031225 | TIMESH ALSO KNOWN AS TIMESH-TC, MODELS 6000001 & 6000004 | Gfe Medizintechnik GmbH | 2003-09-29 | Traditional | PDF ↗ |
| K031955 | MACROPORE SURGI-WRAP MAST BIORESORBABLE SHEET | Macropore Biosurgery, Inc. | 2003-09-22 | Traditional | PDF ↗ |
| K031925 | PROCEED TRILAMINATE SURGICAL MESH | ETHICON, Inc. | 2003-09-17 | Traditional | PDF ↗ |
| K032168 | GORE-TEX DUALMESH EMERGE PLUS BIOMATERIAL | W. L. Gore & Associates, Inc. | 2003-08-15 | Special | PDF ↗ |
| K031188 | ORTHOMEND | Tei Biosciences, Inc. | 2003-06-27 | Abbreviated | PDF ↗ |
| K030631 | ZIPPERE - BIOABSORBABLE/NON-ABSORBABLE POLYMER SLING & SURGICAL MESH | Prosurg, Inc. | 2003-05-19 | Traditional | PDF ↗ |
| K024199 | IMMIX THIN FILM, MODELS: PSS-004-S, PSS-004-SP, PSS-004-M, PSS-004-MP, PSS-004-L, PSS-004-LP | Osteobiologics, Inc. | 2003-03-14 | Traditional | PDF ↗ |
| K022011 | V.A.C. ABDOMINAL DRESSING | Kinetic Concepts, Inc. | 2003-02-26 | Traditional | PDF ↗ |
| K024008 | SMALL BARD VENTRALEX PATCH | C.R. Bard, Inc. | 2003-02-20 | Traditional | PDF ↗ |
| K023328 | REINFORCED ABSORBABLE SYNTHETIC SURGICAL MESH | Center For Biomaterials and Advanced Technologies | 2002-12-12 | Traditional | PDF ↗ |
| K021835 | BRENNEN MEDICAL SURGICAL MESH, GLUCAMESH/GLUCATEX | Brennen Medical, Inc. | 2002-10-17 | Traditional | PDF ↗ |
| K022782 | DUALMESH EMERGE & EMERGE PLUS BIOMATERIAL | W. L. Gore & Associates, Inc. | 2002-09-10 | Special | PDF ↗ |
| K022350 | BARD CRURASOFT PATCH, MODELS 0116003 & 0116001 | C.R. Bard, Inc. | 2002-08-23 | Traditional | PDF ↗ |
| K021736 | BARD VENTRALEX HERNIA PATCH, MODELS 0010302, 0010301 | C.R. Bard, Inc. | 2002-07-16 | Traditional | PDF ↗ |
| K014183 | AFB (ABSORBABLE FOAM BUTTRESS) | J&J Corporate Biomaterials Center | 2002-06-12 | Traditional | PDF ↗ |
| K012025 | MACROPORE SURGIWRAP (TS) | Macropore Biosurgery, Inc. | 2001-12-03 | Traditional | PDF ↗ |
| K010533 | BIOSLING - BIOABSORBABLE POLYMER SLING & SURGICAL MESH | Injectx, Inc. | 2001-05-24 | Traditional | PDF ↗ |
| K010722 | PROLENE (POLYPROPYLENE) 3D PATCH, NONABSORBABLE SYNTHETIC SURGICAL MESH | ETHICON, Inc. | 2001-04-27 | Traditional | PDF ↗ |
| K010035 | IVS TUNNELLER | United States Surgical, A Division of Tyco Healthc | 2001-04-04 | Traditional | PDF ↗ |
| K010228 | GORE-TEX DUALMESH PLUS BIOMATERIAL WITH HOLES | W. L. Gore & Associates, Inc. | 2001-02-21 | Special | PDF ↗ |
| K002699 | PARIETEX COMPOSITE (PCO) MESH | Medical Device Consultants, Inc. | 2001-02-15 | Traditional | PDF ↗ |
| K003906 | MODIFICATION TO FLUROTEX SURGICAL MESH | Bridger Biomed, Inc. | 2001-01-26 | Traditional | PDF ↗ |
| K003917 | MODIFICATION TO FLUOROTEX II SURGICAL MESH | Bridger Biomed, Inc. | 2001-01-26 | Traditional | PDF ↗ |
| K003990 | SOFRADIM PARIETEX SURGICAL MESHES | Sofradim Production | 2001-01-24 | Special | PDF ↗ |
| K003323 | COMPOSIX KUGEL MESH, MODEL 0010201,0010202,0010203,0010204,0010205 | Davol, Inc. | 2001-01-22 | Traditional | PDF ↗ |
| K002721 | AMS TRIANGLE SILICONE-COATED SLING AND SURGICAL MESH | American Medical Systems, Inc. | 2000-11-29 | Traditional | PDF ↗ |
| K002672 | VYPRO MESH, VICRYL PROLENE PARTIALLY ABSORBABLE SYNTHETIC SURGICAL MESH | ETHICON, Inc. | 2000-11-22 | Traditional | PDF ↗ |
| K002479 | BIOMESH P1 AND BIOMESH PLUG AND PATCH | Cousin Biotech S.A.R.L | 2000-10-19 | Traditional | PDF ↗ |
| K002684 | COMPOSIX E/X MESH | C.R. Bard, Inc. | 2000-10-11 | Traditional | PDF ↗ |
| K002351 | FLUOROTEX II SURGICAL MESH | Bridger Biomed, Inc. | 2000-08-26 | Traditional | PDF ↗ |
| K002093 | ATRIUM LITE MESH | Atrium Medical Corp. | 2000-07-24 | Special | PDF ↗ |
| K002071 | SOFTFORM SOFT TISSUE AUGMENTATION TUBE WITH INSERTION TOOL MODIFICATIONS FOR STRANDS AND SUTURE HOLES | Tissue Technologies, Inc. | 2000-07-24 | Traditional | PDF ↗ |
| K001122 | PROLENE SOFT (POLYPROPYLENE), NONABSORBABALE SYNTHETIC SURGICAL MESH | ETHICON, Inc. | 2000-05-23 | Traditional | PDF ↗ |
| K000849 | SOFTFORM FACIAL IMPLANT | Tissue Technologies, Inc. | 2000-05-19 | Traditional | PDF ↗ |
| K994328 | SEPRAMESH BIOSURGICAL COMPOSITE, MODEL SMBC-XXX | Genzyme Corp. | 2000-03-02 | Traditional | PDF ↗ |
| K992556 | PERMACOL | Tissue Science Laboratories, Plc | 2000-02-17 | Traditional | PDF ↗ |
| K000185 | GORE-TEX DUALMESH PLUS BIOMATERIAL (1 MM & 2MM) | W. L. Gore & Associates, Inc. | 2000-02-14 | Special | PDF ↗ |
| K992991 | ATRIUM MEDICAL CORPORATION ADVANTA PTFE FACIAL IMPLANT | Atrium Medical Corp. | 2000-01-27 | Traditional | PDF ↗ |
| K983753 | STAR TEMPORARY WOUND COVER | Osteogenics, Inc. | 1999-11-18 | Traditional | PDF ↗ |
| K992189 | GORE-TEX DUALMESH BIOMATERIAL | W. L. Gore & Associates, Inc. | 1999-07-29 | Special | PDF ↗ |
| K991400 | PARIETENE POLYPROPYLENE MESH | Sofradim Production | 1999-07-12 | Traditional | PDF ↗ |
| K991637 | BARD SPERMA-TEX PRESHAPED MESH (2.4X5.6), MODEL 0114700 | Davol Inc., Sub. C. R. Bard, Inc. | 1999-06-22 | Traditional | PDF ↗ |
| K990930 | 3D ANATOMICAL MESH | Santerra Medical Technology, Inc. | 1999-06-17 | Traditional | PDF ↗ |
| K984220 | MODIFICATION OF PROLENE (POLYPROPYLENE) HERNIA SYSTEM, NONABSORBABLE SYNTHETIC SURGICAL MESH | ETHICON, Inc. | 1999-02-23 | Traditional | PDF ↗ |
| K982532 | PARIETEX | Cogent | 1999-01-20 | Traditional | PDF ↗ |
| K984197 | FLUOROTEX SURGICAL MESH | Bridger Biomed, Inc. | 1999-01-07 | Traditional | PDF ↗ |
| K982575 | MESH, SURGICAL, POLYMERIC | United States Surgical, A Division of Tyco Healthc | 1998-11-06 | Traditional | PDF ↗ |
| K982475 | SOFT TISSUE AUGMENTATION YUBE WITH INSERTION TOOL | Tissue Technologies, Inc. | 1998-09-22 | Traditional | PDF ↗ |
| K981756 | SHELHIGH NO-REACT PNEUMOPLEDGETS | Shelhigh, Inc. | 1998-08-05 | Traditional | PDF ↗ |
| K974540 | SIS HERNIA REPAIR DEVICE | Sentron Medical, Inc. | 1998-05-20 | Traditional | PDF ↗ |
| K973955 | HERNIAMESH SURGICAL MESHES | Herniamesh | 1998-05-11 | Traditional | PDF ↗ |
| K980483 | MENTOR SUSPEND SLING | Mentor Corp. | 1998-04-30 | Traditional | PDF ↗ |
| K981051 | SOFT TISSUE PATCH PLUS, DUALMESH PLUS, MYCROMESH PLUS, DUALMESH PLUS WITH HOLES | W. L. Gore & Associates, Inc. | 1998-04-15 | Traditional | PDF ↗ |
| K973462 | SOFTFORM FACIAL IMPLANT | Tissue Technologies, Inc. | 1997-11-24 | Traditional | PDF ↗ |
| K973082 | VENTRAL WALL DEFECT REDUCTION SILO | Specialty Surgical Products, Inc. | 1997-11-04 | Traditional | PDF ↗ |
| K972412 | PROLENE POLYPROPYLENE MESH HERNIA DEVICE NONABSORBABLE SYNTHETIC SURGICAL MESH | ETHICON, Inc. | 1997-09-10 | Traditional | PDF ↗ |
| K971745 | BARD COMPOSITE PROSTHESIS | Davol Inc., Sub. C. R. Bard, Inc. | 1997-08-06 | Traditional | PDF ↗ |
| K970561 | GRAFT PATCH | Organogenesis, Inc. | 1997-08-01 | Traditional | PDF ↗ |
| K971472 | SIL-TEC NONREINFORCED SHEETING, REINFORCED SHEETING, RADIOPAQUE SHEETING, REINFORCED RADIOPAQUE SHEETING, EXTRA FIRM GRA | Technical Products, Inc. | 1997-07-01 | Traditional | PDF ↗ |
| K964857 | RAPISEAL PATCH | Fusion Medical Technologies, Inc. | 1997-02-18 | Traditional | PDF ↗ |
| K965038 | GORE-TEX SOFT TISSUE PATCH PLUS/DUALMESH PLUS BIOMATERIAL/MYCROMESH PLUS BIOMATERIAL/DUALMESH PLUS BIOMATERIAL WITH HOLE | W. L. Gore & Associates, Inc. | 1997-02-06 | Traditional | PDF ↗ |
| K964761 | S.A.M. FACIAL IMPLANT W/INTRODUCER | W. L. Gore & Associates, Inc. | 1997-01-27 | Traditional | PDF ↗ |
| K963226 | SURGICAL FABRICS | Boston Scientific Corp | 1996-11-15 | Traditional | PDF ↗ |
| K963619 | GORE-TEX SOFT TISSUE PATCH,MYCROMESHA BIOMATERIAL,DUALMESH BIOMATERIAL,DUALMESH BIOMATERIAL WITH HOLES | W. L. Gore & Associates, Inc. | 1996-10-25 | Traditional | PDF ↗ |
| K963141 | KUGEL HERNIA PATCH | Douglas Bueschel | 1996-10-11 | Traditional | PDF ↗ |
| K962971 | POLYPROPYLENE MESH (VARIOUS SIZES) | Davis & Geck, Inc. | 1996-09-16 | Traditional | PDF ↗ |
| K962401 | GORE-TEX DUALMESH PLUS BIOMATERIAL WITH HOLES | W. L. Gore & Associates, Inc. | 1996-09-03 | Traditional | PDF ↗ |
| K962496 | SOFT TISSUE AUGMENTATION TUBE (S.T.A.T.) | Tissue Technologies, Inc. | 1996-09-03 | Traditional | PDF ↗ |
| K962530 | PROLENE POLYPROPYLENE MESH NONABSORBABLE SYNTHETIC SURGICAL MESH | ETHICON, Inc. | 1996-08-09 | Traditional | PDF ↗ |
| K961440 | SURGICAL PATCH, SURGICAL MEMBRANE, SURGICAL MESH | Fusion Medical Technologies, Inc. | 1996-05-31 | Traditional | PDF ↗ |
Product code FTL · Class II · General, Plastic Surgery. Data: openFDA.