REPOL ANGIMESH, ANGIMESH PRE, FOLDED MESH, REPOL PLUG BASIC, REPOL PLUG CAP, REPOL PLUG FLOWER AND WINGS MESH— 510(k) K043191

Name: FDA 510(k) clearance K043191
Creator: U.S. Food and Drug Administration
Published: 2005-05-16

Substantially Equivalent

Angiologica B. M. Srl

FDA 510(k) clearance K043191 for REPOL ANGIMESH, ANGIMESH PRE, FOLDED MESH, REPOL PLUG BASIC, REPOL PLUG CAP, REPOL PLUG FLOWER AND WINGS MESH, Substantially Equivalent on 2005-05-16. Applicant: Angiologica B. M. Srl. Device class: 2.

Clearance details

Applicant: Angiologica B. M. Srl
Product code: Code FTL
Device class: Class 2
Regulation: 21 CFR 878.3300
Advisory panel: General, Plastic Surgery
Date received: 2004-11-17
Decision date: 2005-05-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Martino Siccomario, Pavia, IT

Download summary PDF View on FDA.gov ↗

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Adverse events under product code FTL

product code FTL

Death: 317
Injury: 66,072
Malfunction: 1,273
Other: 3
Total: 67,665

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.