ENVELA (HYDROHESIVE OCCLUSIVE DRESSING)— 510(k) K072560

Substantially Equivalent

Teikoku Pharma USA, Inc.

FDA 510(k) clearance K072560 for ENVELA (HYDROHESIVE OCCLUSIVE DRESSING), Substantially Equivalent on 2008-06-17. Applicant: Teikoku Pharma USA, Inc..

Clearance details

Applicant: Teikoku Pharma USA, Inc.
Product code: Code NAD
Advisory panel: General, Plastic Surgery
Date received: 2007-09-11
Decision date: 2008-06-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Jose, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code NAD

product code NAD

Injury: 431
Malfunction: 11,935
Other: 1
Total: 12,367

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.