DERMASSIST WET DRESSING, SALINE— 510(k) K940044

Substantially Equivalent

Wilshire Medical Products

FDA 510(k) clearance K940044 for DERMASSIST WET DRESSING, SALINE, Substantially Equivalent on 1994-03-03. Applicant: Wilshire Medical Products.

Clearance details

Applicant: Wilshire Medical Products
Product code: Code FRO
Advisory panel: Unknown
Date received: 1994-01-05
Decision date: 1994-03-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dallas, 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.