AIRFRAME SURGICAL DRAPE SUPPORT— 510(k) K942699

Substantially Equivalent

Alpha Surgical, Inc.

FDA 510(k) clearance K942699 for AIRFRAME SURGICAL DRAPE SUPPORT, Substantially Equivalent on 1994-07-13. Applicant: Alpha Surgical, Inc..

Clearance details

Applicant: Alpha Surgical, Inc.
Product code: Code BWN
Advisory panel: General, Plastic Surgery
Date received: 1994-06-08
Decision date: 1994-07-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Eau Claire, WI, US

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Adverse events under product code BWN

product code BWN

Other: 1
Total: 1

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.