PERMACOL— 510(k) K013625

Name: FDA 510(k) clearance K013625
Creator: U.S. Food and Drug Administration
Published: 2002-01-17

Substantially Equivalent

Tissue Science Laboratories, Plc

FDA 510(k) clearance K013625 for PERMACOL, Substantially Equivalent on 2002-01-17. Applicant: Tissue Science Laboratories, Plc. Device class: 2.

Clearance details

Applicant: Tissue Science Laboratories, Plc
Product code: Code FTM
Device class: Class 2
Regulation: 21 CFR 878.3300
Advisory panel: General, Plastic Surgery
Date received: 2001-11-05
Decision date: 2002-01-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, US

Download summary PDF View on FDA.gov ↗

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More clearances from Tissue Science Laboratories, Plc

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K053562 — ZIMMER COLLAGEN REPAIR PATCH2006-06-23
K050355 — PERMACOL SURGICAL IMPLANT T-PIECE, PERMACOL SURGICAL IMPLANT RECTOCELE-PIECE, MODELS 5928-150, 5645-1502005-03-09
K043366 — PERMACOL SURGICAL IMPLANT2004-12-17
K021056 — PERMACOL2002-10-31
K992556 — PERMACOL2000-02-17

Adverse events under product code FTM

product code FTM

Death: 17
Injury: 2,174
Total: 2,191

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.