TEGADERM TRANSPARENT DRESSING— 510(k) K811291

Substantially Equivalent

3M Company

FDA 510(k) clearance K811291 for TEGADERM TRANSPARENT DRESSING, Substantially Equivalent on 1981-06-02. Applicant: 3M Company.

Clearance details

Applicant: 3M Company
Product code: Code KGX
Advisory panel: General Hospital
Date received: 1981-05-11
Decision date: 1981-06-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: White City, OR, 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.