Proceed
PROCEED Surgical Mesh 25 cm x 35.5 cm (10" x 14") Rectangular
1manufacturer
13catalogue numbers in this listing
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 | Johnson & Johnson Medical GmbH, Germany |
|---|---|
| FDA product code | FTL |
| Device type | Mesh, Surgical, Polymeric |
| Device class | Class 2 |
| Regulation | 21 CFR 878.3300 |
| Establishment | Contract manufacturer, Manufacturer |
| 510(k) | K060713 |
| Record published | 2015-09-23 |
| Record revised | 2023-01-31 (version 12) |
Specifications
| MRI safety | MR Safe |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Packaging | Box of 2 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| PCDN1 | In distribution | |
| PCDR1 | In distribution | |
| PVPM | In distribution | |
| PCDH1 | In distribution | |
| PVPS | In distribution | |
| PCDM1 | In distribution | |
| PCDW1 | In distribution | |
| PCDJ1 | In distribution | |
| PCDL1 | In distribution | |
| PCDB1 | In distribution | |
| PCDG1 | In distribution | |
| PCDD1 | In distribution | |
| PCDT1 | 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
Recalls Naming This Product
2 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Ethicon, Inc. | 510(k) number | 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 |
| Ethicon, Inc. | 510(k) number | 2010-10-18 | Not classified | Nonconforming Material/Component | There is a potential for delamination in one lot of Proceed surgical mesh. | 87 products |
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.