Gore-TEX Soft Tissue Patch
GORE-TEX SOFT TISSUE PATCH 26.0cmX34.0cmX1.0mm Oval
1manufacturer
13catalogue numbers in this listing
37510(k) clearances naming this product code
1recall
Who Else Makes It
Registered in Shanghai.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shanghai Suokang Medical Implants Co., Ltd. | Shang Hai | Shanghai | Manufacturer | 2 |
Record
| Listed by | W. L. Gore & Associates, Inc., United States |
|---|---|
| FDA product code | FTL |
| Device type | Mesh, Surgical, Polymeric |
| Device class | Class 2 |
| Regulation | 21 CFR 878.3300 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K963619 |
| Record published | 2017-01-26 |
| Record revised | 2025-08-18 (version 11) |
Specifications
| MRI safety | MR Safe |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | expiry date, manufacturing date, serial number |
| Sizes | Height 1 to 2 mm; length 10 to 34 cm; width 5 to 26 cm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1305010020 | Height 2 mm | In distribution |
| 1305015020 | Width 5 cm | In distribution |
| 1405010010 | Height 1 mm | In distribution |
| 1320030020 | Height 2 mm | In distribution |
| 1405015010 | Height 1 mm | In distribution |
| 1415020010 | Height 1 mm | In distribution |
| 132603402A | Width 26 cm | In distribution |
| 1315020020 | Width 15 cm | In distribution |
| 140501001B | Width 5 cm | In distribution |
| 142603401A | Height 1 mm | In distribution |
| 1420030010 | Width 20 cm | In distribution |
| 1310015020 | Width 10 cm | In distribution |
| 1410015010 | Width 10 cm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Technical Products | Technical Products, Inc. | 143 |
| Parietex | Sofradim Production | 82 |
| DynaMesh | FEG Textiltechnik Forschungs- und Entwicklungsges. mbH | 45 |
| Symbotex | Sofradim Production | 35 |
| Silicone Sheeting Reinforced | Bentec Medical OpCo, LLC. | 33 |
| Parietene | Sofradim Production | 32 |
| C-QUR | Atrium Medical Corporation | 31 |
| ProGrip | Sofradim Production | 31 |
| Silicone Sheeting Non-Reinforced | Bentec Medical OpCo, LLC. | 31 |
| Prolite | Atrium Medical Corporation | 31 |
| Gore Seamguard Bioabsorbable Staple Line Reinforce | W. L. Gore & Associates, Inc. | 30 |
| Surgimesh®wn | Aspide Medical | 28 |
Showing 12 of 148. All products under Mesh, Surgical, Polymeric
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K163576 | 2017-05-11 |
| K152609 | 2015-12-11 |
| K083266 | 2009-03-27 |
| K081069 | 2008-05-30 |
| K070644 | 2007-04-02 |
| K063435 | 2006-11-28 |
| K053200 | 2005-12-07 |
| K053202 | 2005-12-07 |
| K043056 | 2004-12-22 |
| K043081 | 2004-12-22 |
| K032865 | 2003-11-28 |
| K032168 | 2003-08-15 |
| K022782 | 2002-09-10 |
| K010228 | 2001-02-21 |
| K000185 | 2000-02-14 |
| K992189 | 1999-07-29 |
| K981051 | 1998-04-15 |
| K965038 | 1997-02-06 |
| K964761 | 1997-01-27 |
| K963619 | 1996-10-25 |
| K962401 | 1996-09-03 |
| K955494 | 1996-01-24 |
| K952898 | 1995-11-14 |
| K951700 | 1995-10-07 |
| K951676 | 1995-10-07 |
| K951675 | 1995-10-07 |
| K946106 | 1995-04-24 |
| K946107 | 1995-04-24 |
| K945899 | 1995-02-13 |
| K922452 | 1994-09-29 |
| K930822 | 1994-01-28 |
| K926478 | 1993-11-29 |
| K931150 | 1993-10-29 |
| K926565 | 1993-09-09 |
| K914449 | 1991-12-04 |
| K833764 | 1984-01-10 |
| K820193 | 1982-03-26 |
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|
| 2024-07-03 | Class II | Process control | Devices were labeled with an expiration date of four years and ten days rather than the validated two years. | 51 units |
PMA Approvals
A premarket approval is the full Class III route, granted on clinical evidence rather than on equivalence to an existing device. It is the highest regulatory bar a device of this type can clear.
| PMA number | Decision | Trade name | Approved to |
|---|---|---|---|
| P990028 | 2003-12-04 | FOCALSEAL-L SYNTHETIC ABSORBABLE SEALANT | Genzyme Corporation |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.