Tephaflex Absorbable Suture
FDA 510(k)Class II (US FDA 510(k))
by Tepha, Inc.
Identifiers
- 510(k) Number
- DEN060003 FDA 510(k)
- FDA Product Code
- NWJ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 878.4494 FDA 510(k)
- Regulation Number
- 878.4494 FDA 510(k)
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- DENG FDA 510(k)
The Tephaflex Absorbable Suture is a monofilament, absorbable surgical suture constructed from poly-4-hydroxybutyrate. Classified as a suture under the nomenclature for recombinant technology, it is designed for general soft tissue approximation and ligation, excluding use in cardiovascular, neurological, microsurgical, or ophthalmic applications.
Supplied sterile and intended for single-use, this suture is regulated under FDA 510(k) clearance (K081099) and falls under device class II. It is manufactured by Tepha, Inc., and distributed in sizes referenced by the product codes NWJ, 3003639970, 3000718467, and 2183744. Storage and handling must comply with sterile surgical instrument protocols.
Frequently asked questions
What types of tissues can the Tephaflex Absorbable Suture be used for, and what are its limitations?
The Tephaflex Absorbable Suture is designed for general soft tissue approximation and ligation, meaning it can be used to sew together or tie off soft tissues like skin, muscle, or fascia. However, it is explicitly not intended for use in cardiovascular, neurological, microsurgical, or ophthalmic procedures. This limitation is due to its material properties and intended classification, ensuring it is not used in delicate or high-stakes areas where precision and biocompatibility requirements differ.
How is the Tephaflex Absorbable Suture supplied, and what sizes or models are available?
The suture is supplied sterile and intended for single-use only, adhering to standard sterile surgical instrument protocols. It comes in multiple sizes, referenced by the product codes NWJ, 3003639970, 3000718467, and 2183744. These codes correspond to specific suture gauges or configurations, though exact measurements (e.g., diameter or length) are not detailed in the provided data. Always verify the correct size against the packaging or manufacturer’s documentation for your procedure.
Is the Tephaflex Absorbable Suture reusable, and what storage guidelines should be followed?
No, the Tephaflex Absorbable Suture is intended for single-use only, as indicated in its design and regulatory classification. Storage must comply with sterile surgical instrument protocols to maintain integrity. This means keeping it in a sealed, sterile package until use and avoiding contamination or exposure to conditions that could compromise sterility, such as moisture or direct light.
What regulatory pathway does the Tephaflex Absorbable Suture follow, and how does that affect its use?
The Tephaflex Absorbable Suture follows the FDA 510(k) clearance pathway, specifically under clearance number K081099 and classified as a Class II device. This means it has undergone FDA review to demonstrate substantial equivalence to a predicate device and meets performance standards for absorbable sutures. Clinicians can rely on this clearance to confirm its safety and effectiveness for the intended general soft tissue applications, though it remains excluded from cardiovascular, neurological, microsurgical, or ophthalmic use.
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: TephaFLEX Absorbable Monofilament Suture - Medical XPRT, PDF JUL 1 i 2008 - Food and Drug Administration, TEPHAFLEX ABSORBABLE SUTURE (K081099) — FDA 510(k) | Innolitics
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | DEN060003 | Class II | Active |
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Manufacturer
- Manufacturer
- Tepha, Inc.
Sources (1)
- FDA 510(k) DEN060003 24 fields · synced Sep 19, 2026