SURGISEAL TWIST (TM) TOPICAL SKIN ADHESIVE— 510(k) K133963

Substantially Equivalent

Adhezion Biomedical, LLC

FDA 510(k) clearance K133963 for SURGISEAL TWIST (TM) TOPICAL SKIN ADHESIVE, Substantially Equivalent on 2014-09-09. Applicant: Adhezion Biomedical, LLC.

Clearance details

Applicant: Adhezion Biomedical, LLC
Product code: Code MPN
Advisory panel: General, Plastic Surgery
Date received: 2013-12-24
Decision date: 2014-09-09
Decision: Substantially Equivalent
Clearance type: Special
Location: Wyomissing, PA, US

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Adverse events under product code MPN

product code MPN

Injury: 856
Other: 1
Total: 857

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.