AESCULAP HISTOACRYL FLEXIBLE TOPICAL SKIN ADHESIVE— 510(k) K121976

Name: FDA 510(k) clearance K121976
Creator: U.S. Food and Drug Administration
Published: 2013-05-17

Substantially Equivalent

Aesculap, Inc.

FDA 510(k) clearance K121976 for AESCULAP HISTOACRYL FLEXIBLE TOPICAL SKIN ADHESIVE, Substantially Equivalent on 2013-05-17. Applicant: Aesculap, Inc.. Device class: 2.

Clearance details

Applicant: Aesculap, Inc.
Product code: Code MPN
Device class: Class 2
Regulation: 21 CFR 878.4010
Advisory panel: General, Plastic Surgery
Date received: 2012-07-05
Decision date: 2013-05-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Center Valley, 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.