LEUKOSPORT(TM) ADHESIVE TAPE— 510(k) K894367

Substantially Equivalent for Some Indications

Beiersdorf, Inc.

FDA 510(k) clearance K894367 for LEUKOSPORT(TM) ADHESIVE TAPE, Substantially Equivalent for Some Indications on 1989-11-15. Applicant: Beiersdorf, Inc..

Clearance details

Applicant: Beiersdorf, Inc.
Product code: Code KGX
Advisory panel: General Hospital
Date received: 1989-07-14
Decision date: 1989-11-15
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Norwalk, CT, 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.