UNITED SKIN BARRIER— 510(k) K770982

Substantially Equivalent

Howmedica Corp.

FDA 510(k) clearance K770982 for UNITED SKIN BARRIER, Substantially Equivalent on 1977-07-15. Applicant: Howmedica Corp..

Clearance details

Applicant: Howmedica Corp.
Product code: Code EXE
Advisory panel: Gastroenterology, Urology
Date received: 1977-05-31
Decision date: 1977-07-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Adverse events under product code EXE

product code EXE

Injury: 205
Malfunction: 11,191
Total: 11,396

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.