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

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..

Clearance details

Applicant: Bioform, Inc.
Product code: Code NEU
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.