COAPTITE TISSUE MARKER AND COAPTITE FN TISSUE MARKER— 510(k) K012955

Name: FDA 510(k) clearance K012955
Creator: U.S. Food and Drug Administration
Published: 2001-10-22

Substantially Equivalent

Bioform, Inc.

FDA 510(k) clearance K012955 for COAPTITE TISSUE MARKER AND COAPTITE FN TISSUE MARKER, Substantially Equivalent on 2001-10-22. Applicant: Bioform, Inc.. Device class: 2.

Clearance details

Applicant: Bioform, Inc.
Product code: Code NEU
Device class: Class 2
Regulation: 21 CFR 878.4300
Advisory panel: General, Plastic Surgery
Date received: 2001-09-04
Decision date: 2001-10-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Franksville, WI, US

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Adverse events under product code NEU

product code NEU

Injury: 824
Total: 824

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.