AIRSTRIP FIRST AID & POST-OP DRESSING— 510(k) K911682

Substantially Equivalent

Smith & Nephew United, Inc.

FDA 510(k) clearance K911682 for AIRSTRIP FIRST AID & POST-OP DRESSING, Substantially Equivalent on 1991-07-17. Applicant: Smith & Nephew United, Inc..

Clearance details

Applicant: Smith & Nephew United, Inc.
Product code: Code KGX
Advisory panel: General Hospital
Date received: 1991-04-15
Decision date: 1991-07-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Largo, FL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code KGX

product code KGX

Injury: 1,590
Malfunction: 1,357
Other: 3
Total: 2,950

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.