Identifiers
- 510(k) Number
- K082176 FDA 510(k)
- FDA Product Code
- FTM FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 878.3300 FDA 510(k)
- Regulation Number
- 878.3300 FDA 510(k)
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Ltm-Bps Surgical Mesh is a medical device derived from porcine skin. It consists of a processed porcine dermal matrix provided in prescribed geometric configurations and thicknesses.
This device is supplied as a terminally sterilized sheet in a double pouch configuration. It is regulated under 21 CFR 878.3300 and has received FDA 510(k) clearance.
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: LTM-BPS SURGICAL MESH (K082176) — FDA 510(k) | Innolitics, PDF NOV 1 4 2008 - Food and Drug Administration, LTM-BPS SURGICAL MESH 510 (k) K082176 - FDA.report
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K082176 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Lifecell Corp.
Sources (1)
- FDA 510(k) K082176 24 fields · synced Sep 22, 2026