Force Fiber Polyethylene Nonabsorbable Suture
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K063778 FDA 510(k)
- FDA Product Code
- GAT FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 878.5000 FDA 510(k)
- Regulation Number
- 878.5000 FDA 510(k)
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Force Fiber Polyethylene Nonabsorbable Suture is a 100% ultra-high molecular weight polyethylene (UHMWPE) orthopedic suture that offers greater tensile strength than polyester and polyblend sutures. It features a proprietary coreless braid configuration that creates a pliable, easy-to-handle suture with superior knot break strength and low knot profile for precise placement.
The suture is supplied in black for better contrast against surrounding tissue and is nonabsorbable. It is manufactured by Teleflex Medical and has FDA 510K clearance with product code GAT. The device is intended for use in general and plastic surgery applications.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Force Fiber®Suture ‹ Teleflex Medical, Black Force Fiber Suture ‹ Teleflex Medical, Force Fiber® Suture - Teleflex Medical OEM
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K063778 | Class II | Active |
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Manufacturer
- Manufacturer
- Teleflex Medical
Sources (1)
- FDA 510(k) K063778 24 fields · synced Sep 24, 2026