VIVOSORB SHEET, MODEL FS01— 510(k) K042811

Name: FDA 510(k) clearance K042811
Creator: U.S. Food and Drug Administration
Published: 2004-11-08

Substantially Equivalent

Polyganics B.V.,

FDA 510(k) clearance K042811 for VIVOSORB SHEET, MODEL FS01, Substantially Equivalent on 2004-11-08. Applicant: Polyganics B.V.,. Device class: 2.

Clearance details

Applicant: Polyganics B.V.,
Product code: Code FTL
Device class: Class 2
Regulation: 21 CFR 878.3300
Advisory panel: General, Plastic Surgery
Date received: 2004-10-12
Decision date: 2004-11-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Groningen, NL

Download summary PDF View on FDA.gov ↗

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K112267 — NEUROLAC(R) NERVE GUIDE2011-10-20
K070715 — NASOPORE EAR2007-05-07
K062540 — NASOPORE EAR, MODELS ND04, ND052006-10-18

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.