GENESIS— 510(k) K942553

Substantially Equivalent

Burton Medical Products Corp.

FDA 510(k) clearance K942553 for GENESIS, Substantially Equivalent on 1994-06-23. Applicant: Burton Medical Products Corp..

Clearance details

Applicant: Burton Medical Products Corp.
Product code: Code FTD
Advisory panel: General, Plastic Surgery
Date received: 1994-05-31
Decision date: 1994-06-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chatsworth, CA, US

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Adverse events under product code FTD

product code FTD

Malfunction: 767
Total: 767

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.