COMFEEL ULCUS ULCER CARE SYSTEM— 510(k) K873669

Substantially Equivalent for Some Indications

Coloplast A/S

FDA 510(k) clearance K873669 for COMFEEL ULCUS ULCER CARE SYSTEM, Substantially Equivalent for Some Indications on 1987-11-17. Applicant: Coloplast A/S.

Clearance details

Applicant: Coloplast A/S
Product code: Code FRO
Advisory panel: Unknown
Date received: 1987-09-11
Decision date: 1987-11-17
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Fort Woth, TX, 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.