LYOFOAM WOUND DRESSINGS— 510(k) K860085

Substantially Equivalent for Some Indications

Acme United Corp.

FDA 510(k) clearance K860085 for LYOFOAM WOUND DRESSINGS, Substantially Equivalent for Some Indications on 1986-06-27. Applicant: Acme United Corp..

Clearance details

Applicant: Acme United Corp.
Product code: Code NAD
Advisory panel: General, Plastic Surgery
Date received: 1986-01-09
Decision date: 1986-06-27
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Fairfield, CT, 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.