OPSITE*WOUND (FLEXIGRID APPLICATION SYSTEM)— 510(k) K895408

Substantially Equivalent

Smith & Nephew United, Inc.

FDA 510(k) clearance K895408 for OPSITE*WOUND (FLEXIGRID APPLICATION SYSTEM), Substantially Equivalent on 1989-12-14. Applicant: Smith & Nephew United, Inc..

Clearance details

Applicant: Smith & Nephew United, Inc.
Product code: Code KGX
Advisory panel: General Hospital
Date received: 1989-09-06
Decision date: 1989-12-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Largo, FL, US

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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.