Mersilene
Mersilene Polyester Fiber Ligature, White Woven, Sterile, Nonabsorbable Surgical Ligature
6manufacturers in China registered for this device type
96catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (2), Shandong (2), Fujian (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Arthrex (Shanghai) Co., Ltd. | Shanghai | Shanghai | Exporter | 38 |
| Shandong Haidike Medical Products Co., Ltd. | Heze | Shandong | Manufacturer | 22 |
| Xiamen Zhiyuan Medical Technology Co., Ltd. | Xiamen | Fujian | Contract manufacturer | 22 |
| Foosin Medical Supplies Inc.ltd | Weihai | Shandong | Manufacturer | 8 |
| ARC Medical Supplies (Beijing) Co., Ltd. | Beijing | Beijing | Manufacturer | 7 |
Record
| Listed by | Ethicon, Inc., United States |
|---|---|
| FDA product code | GAT |
| Device type | Suture, Nonabsorbable, Synthetic, Polyethylene |
| Device class | Class 2 |
| Regulation | 21 CFR 878.5000 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer, Exporter |
| 510(k) | K946173 |
| Record published | 2015-09-01 |
| Record revised | 2026-04-13 (version 10) |
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 |
| Storage | Special storage condition: Do not use if package is opened or damaged |
| Packaging | Box of 12, box of 36, box of 6, box of 24 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| D9416 | In distribution | |
| D7342 | In distribution | |
| D5574 | In distribution | |
| R691G | In distribution | |
| D6036 | In distribution | |
| R749G | In distribution | |
| 740G | In distribution | |
| D7538 | In distribution | |
| D5951 | In distribution | |
| D2135 | In distribution | |
| D7164 | In distribution | |
| D10076 | In distribution | |
| D7278 | In distribution | |
| D9211 | In distribution | |
| R633ZH | In distribution | |
| D8014 | In distribution | |
| R495T | In distribution | |
| D7683 | In distribution | |
| R844H | In distribution | |
| D9086 | In distribution | |
| R690G | In distribution | |
| EH7325H | In distribution | |
| R832H | In distribution | |
| D3909 | In distribution | |
| R665H | In distribution | |
| D2497 | In distribution | |
| DC547 | In distribution | |
| 1778G | In distribution | |
| MR21T | In distribution | |
| RS21 | In distribution | |
| D9433 | In distribution | |
| D5320 | In distribution | |
| D8062 | In distribution | |
| 1722G | In distribution | |
| R995G | In distribution | |
| D8130 | In distribution | |
| D8913 | In distribution | |
| RS23 | In distribution | |
| D1603 | In distribution | |
| D1945 | In distribution | |
| R424H | In distribution | |
| D8113 | In distribution | |
| D3370 | In distribution | |
| D4970 | In distribution | |
| D3860 | In distribution | |
| D9427 | In distribution | |
| EH7164H | In distribution | |
| D9660 | In distribution | |
| D8843 | In distribution | |
| DC450 | In distribution | |
| D3220 | In distribution | |
| D2848 | In distribution | |
| D9878 | In distribution | |
| R833H | In distribution | |
| R756G | In distribution | |
| 1761G | In distribution | |
| D6394 | In distribution | |
| 1762G | In distribution | |
| D7648 | In distribution | |
| D8346 | In distribution | |
| EH7689H | In distribution | |
| R952H | In distribution | |
| R647H | In distribution | |
| EH7350H | In distribution | |
| D9212 | In distribution | |
| 746G | In distribution | |
| D2726 | In distribution | |
| DC296 | In distribution | |
| D9176 | In distribution | |
| 1765G | In distribution | |
| D2167 | In distribution | |
| P1625H | In distribution | |
| D5556 | In distribution | |
| D8125 | In distribution | |
| D4698 | In distribution | |
| D1643 | In distribution | |
| D5789 | In distribution | |
| R845H | In distribution | |
| DC261 | In distribution | |
| D1841 | In distribution | |
| P1626H | In distribution | |
| D3755 | In distribution | |
| D8074 | In distribution | |
| RS22 | In distribution | |
| 1779G | In distribution | |
| R750G | In distribution | |
| 1764G | In distribution | |
| R633H | In distribution | |
| D5751 | In distribution | |
| D8051 | In distribution | |
| D2052 | In distribution | |
| 1760G | In distribution | |
| R689G | In distribution | |
| D6094 | In distribution | |
| R770G | In distribution | |
| D8649 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Premicron | B Braun Surgical SA | 1,377 |
| Deknatel | Teleflex Medical LLC | 1,198 |
| FlexiGRAFT® | LifeNet Health | 992 |
| DemeBOND | Demetech Corp. | 939 |
| Ti-Cron | Covidien LP | 482 |
| HS FIber | Riverpoint Medical LLC | 413 |
| Ethibond Excel | Ethicon, Inc. | 383 |
| Arthrex® | Arthrex, Inc. | 307 |
| Dagrofil | B Braun Surgical SA | 195 |
| WEGO-Polyester Nonabsorbable Surgical Suture With Needle | Foosin Medical Supplies Inc.ltd | 175 |
| Cardioxyl ® | Peters Surgical | 162 |
| Silkam | B Braun Surgical SA | 150 |
Showing 12 of 275. All products under Suture, Nonabsorbable, Synthetic, Polyethylene
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 |
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 |
|---|---|---|---|
| N16374 | 1986-01-23 | PROLENE*POLYPROPYLENE SUTURE NONABSORBABLE SURG. S | Ethicon, Inc. |
| P810028 | 1984-12-17 | DEKLENE(TM) | Deknatel, Inc. |
| N17825 | 1981-09-24 | SURGILENE | Davis & Geck, Inc. |
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.