Mopylen
Mopylen is listed in the FDA filing as part of a family of non-absorbable surgical sutures. The filing describes the sutures as supplied sterile in monofilament, twisted or braided forms,…
Mopylen is listed in the FDA filing as part of a family of non-absorbable surgical sutures. The filing describes the sutures as supplied sterile in monofilament, twisted or braided forms, with or without needles.
The filing states that the sutures are used for wound closure and soft tissue approximation or ligation. Mopylen is one of several named suture lines in the filing; the passage does not assign every listed construction or size to Mopylen individually.
Use and Supply
The filing describes a range of suture sizes and configurations across the subject family. Its indication passage names general soft tissue approximation and ligation; it also specifies additional contexts for some family members. The evidence does not establish which of those family-specific details apply to each Mopylen configuration.
Who Else Makes It
Concentrated in Shandong (2), Beijing (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shandong Haidike Medical Products Co., Ltd. | Heze | Shandong | Manufacturer | 22 |
| Foosin Medical Supplies Inc.ltd | Weihai | Shandong | Manufacturer | 8 |
| ARC Medical Supplies (Beijing) Co., Ltd. | Beijing | Beijing | Manufacturer | 7 |
Record
| Listed by | Resorba Medical GmbH, Germany |
|---|---|
| FDA product code | GAW |
| Device type | Suture, Nonabsorbable, Synthetic, Polypropylene |
| Device class | Class 2 |
| Regulation | 21 CFR 878.5010 |
| Establishment | Manufacturer |
| 510(k) | K143582 |
| Record published | 2019-01-24 |
| Record revised | 2023-10-30 (version 5) |
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, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| MOPYLEN | In distribution | |
| MOPYLEN | In distribution | |
| MOPYLEN | In distribution | |
| MOPYLEN | In distribution | |
| MOPYLEN | In distribution | |
| MOPYLEN | In distribution | |
| MOPYLEN | In distribution | |
| MOPYLEN | In distribution | |
| MOPYLEN | In distribution | |
| MOPYLEN | In distribution | |
| MOPYLEN | In distribution | |
| MOPYLEN | In distribution | |
| MOPYLEN | In distribution | |
| MOPYLEN | In distribution | |
| MOPYLEN | In distribution | |
| MOPYLEN | In distribution | |
| MOPYLEN | In distribution | |
| MOPYLEN | In distribution | |
| MOPYLEN | In distribution | |
| MOPYLEN | In distribution | |
| MOPYLEN | In distribution | |
| MOPYLEN | In distribution | |
| MOPYLEN | In distribution | |
| MOPYLEN | In distribution | |
| MOPYLEN | In distribution | |
| MOPYLEN | In distribution | |
| MOPYLEN | In distribution | |
| MOPYLEN | In distribution | |
| MOPYLEN | In distribution | |
| MOPYLEN | In distribution | |
| MOPYLEN | In distribution | |
| MOPYLEN | In distribution | |
| MOPYLEN | In distribution | |
| MOPYLEN | In distribution | |
| MOPYLEN | In distribution | |
| MOPYLEN | In distribution | |
| MOPYLEN | In distribution | |
| MOPYLEN | In distribution | |
| MOPYLEN | In distribution | |
| MOPYLEN | In distribution | |
| MOPYLEN | In distribution | |
| MOPYLEN | In distribution | |
| MOPYLEN | In distribution | |
| MOPYLEN | In distribution | |
| MOPYLEN | In distribution | |
| MOPYLEN | In distribution | |
| MOPYLEN | In distribution | |
| MOPYLEN | In distribution | |
| MOPYLEN | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| DemeLENE | Demetech Corp. | 1,707 |
| Premilene | B Braun Surgical SA | 1,247 |
| Optilene | B Braun Surgical SA | 1,110 |
| Prolene | Ethicon, Inc. | 765 |
| Deknatel | Teleflex Medical LLC | 373 |
| Corolene® | Peters Surgical | 354 |
| WEGO-Polypropylene Nonabsorbable Surgical Suture With Needle | Foosin Medical Supplies Inc.ltd | 346 |
| Surgipro II | Covidien LP | 254 |
| Surgipro ll | Covidien LP | 152 |
| Atramat | Internacional Farmacéutica S.A DE C.V | 140 |
| Surgipro | Covidien LP | 133 |
| Filaprop | Meril Endo Surgery PVT. Ltd. | 123 |
Showing 12 of 200. All products under Suture, Nonabsorbable, Synthetic, Polypropylene
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K143582 | 2015-10-29 |
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 |
|---|---|---|---|
| P890002 | 1989-05-31 | POLYPROPYLENE SURGICAL SUTURE | Alcon Laboratories, Inc. |
| P820083 | 1986-08-05 | GORE-TEX(R) EXPANDED PTFE SUTURE | W. L. Gore & Associates, 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.