HYPAFIX DRESSING RETENTION SHEET— 510(k) K894254

Substantially Equivalent

Smith & Nephew United, Inc.

FDA 510(k) clearance K894254 for HYPAFIX DRESSING RETENTION SHEET, Substantially Equivalent on 1989-08-31. Applicant: Smith & Nephew United, Inc..

Clearance details

Applicant: Smith & Nephew United, Inc.
Product code: Code NAD
Advisory panel: General, Plastic Surgery
Date received: 1989-06-20
Decision date: 1989-08-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Largo, FL, US

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Adverse events under product code NAD

product code NAD

Injury: 431
Malfunction: 11,935
Other: 1
Total: 12,367

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.