OMIDERM WOUND & BURN DRESSING— 510(k) K851885

Substantially Equivalent for Some Indications

Biosystems Assoc.

FDA 510(k) clearance K851885 for OMIDERM WOUND & BURN DRESSING, Substantially Equivalent for Some Indications on 1985-11-25. Applicant: Biosystems Assoc..

Clearance details

Applicant: Biosystems Assoc.
Product code: Code FRO
Advisory panel: Unknown
Date received: 1985-04-30
Decision date: 1985-11-25
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: La Jolla, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code FRO

product code FRO

Death: 30
Injury: 653
Malfunction: 479
Other: 11
Total: 1,173

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.