Mersilene
White Woven Polyester Fiber, Nonabsorbable Surgical Ligature
1manufacturer
2catalogue numbers in this listing
3510(k) clearances naming this product code
2recalls on this code
Who Else Makes It
Registered in Shandong.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Foosin Medical Supplies Inc.ltd | Weihai | Shandong | Manufacturer | 8 |
Record
| Listed by | Ethicon, Inc., United States |
|---|---|
| FDA product code | GAQ |
| Device type | Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4495 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer, Exporter |
| 510(k) | K946173 |
| Record published | 2015-09-01 |
| Record revised | 2026-04-13 (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 12, box of 6 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| D10117 | In distribution | |
| RS20 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Ethibond Excel | Ethicon, Inc. | 175 |
| DemeSTEEL | Demetech Corp. | 150 |
| Deknatel | Teleflex Medical LLC | 94 |
| Ethicon | Ethicon, Inc. | 73 |
| Steel | Covidien LP | 44 |
| Acier | Peters Surgical | 43 |
| E-Pack | Ethicon, Inc. | 17 |
| Ethi-PAK | Ethicon, Inc. | 11 |
| Steel Wire | Resorba Medical GmbH | 10 |
| Steelex | B Braun Surgical SA | 7 |
| Valkyrie | Surgical Specialties México, S. de R.L. de C.V. | 6 |
| Fumedica | Surgical Specialties México, S. de R.L. de C.V. | 6 |
Showing 12 of 26. All products under Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K170767 | 2017-11-01 |
| K946173 | 1995-01-09 |
| K931271 | 1994-01-07 |
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 | 2019-04-19 | Class II | Material/Component Contamination | Possibility that a suture raw material containing high endotoxin levels was used in the manufacturing of this lot | 1296 eaches | 2021-02-05 |
| Ethicon, Inc. | 510(k) number | 2019-04-19 | Class II | Material/Component Contamination | Possibility that a suture raw material containing high endotoxin levels was used in the manufacturing of this lot | 36 eaches | 2021-02-05 |
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.