ACU-DISPO-CE(TM)— 510(k) K933265

Substantially Equivalent

Acuderm, Inc.

FDA 510(k) clearance K933265 for ACU-DISPO-CE(TM), Substantially Equivalent on 1994-03-07. Applicant: Acuderm, Inc..

Clearance details

Applicant: Acuderm, Inc.
Product code: Code MDM
Advisory panel: General, Plastic Surgery
Date received: 1993-07-06
Decision date: 1994-03-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ft. Lauderdale, FL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code MDM

product code MDM

Injury: 247
Malfunction: 1,516
Total: 1,763

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.