Vicryl
Undyed Knitted (Polyglactin 910), Synthetic Absorbable Mesh
1manufacturer
4catalogue numbers in this listing
25510(k) clearances naming this product code
3recalls on this code
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 | Ethicon, Inc., United States |
|---|---|
| FDA product code | FTL |
| Device type | Mesh, Surgical, Polymeric |
| Device class | Class 2 |
| Regulation | 21 CFR 878.3300 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer, Exporter |
| Record published | 2015-09-01 |
| Record revised | 2025-08-18 (version 8) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Packaging | Box of 3 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| VKML | In distribution | |
| VKMM | In distribution | |
| VWML | In distribution | |
| VWMM | 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 |
|---|---|
| K201143 | 2020-08-06 |
| K191373 | 2019-10-22 |
| K181268 | 2018-07-26 |
| K180910 | 2018-07-02 |
| K180829 | 2018-06-28 |
| K172089 | 2017-10-05 |
| K163152 | 2017-03-11 |
| K141560 | 2014-10-23 |
| K133198 | 2014-05-30 |
| K093932 | 2010-04-09 |
| K082216 | 2008-09-05 |
| K071249 | 2007-06-05 |
| K070224 | 2007-04-17 |
| K061533 | 2006-12-11 |
| K060713 | 2006-05-25 |
| K051701 | 2005-09-29 |
| K033337 | 2004-04-01 |
| K031925 | 2003-09-17 |
| K010722 | 2001-04-27 |
| K002672 | 2000-11-22 |
| K001122 | 2000-05-23 |
| K984220 | 1999-02-23 |
| K972412 | 1997-09-10 |
| K962530 | 1996-08-09 |
| K810428 | 1981-03-13 |
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 | Closed |
|---|---|---|---|---|---|
| 2020-10-23 | Class II | Under Investigation by firm | The firm is recalling the PROCEED Surgical Mesh device, because it is a sterile device, and a customer found a hair inside of the primary packaging of a single unit. | 295 units distributed. Only 15 units are being recalled. | 2022-12-21 |
| 2010-10-18 | Not classified | Nonconforming Material/Component | There is a potential for delamination in one lot of Proceed surgical mesh. | 87 products | |
| 2006-01-04 | Not classified | Other | Lots of Proceed Surgical Mesh may delaminate from the polypropylene mesh during certain hernia repairs. Exposure of the polypropylene layer to the bowel prior to reperitonealization could increase the risk of adhesions and bowel fistulizat | 18,270 devices | 2006-09-28 |
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.