DERMASSIST(TM) HYDROGEL SATURATEED NON WOVEN DRESSING— 510(k) K946031

Substantially Equivalent

Wilshire Medical Products

FDA 510(k) clearance K946031 for DERMASSIST(TM) HYDROGEL SATURATEED NON WOVEN DRESSING, Substantially Equivalent on 1995-02-27. Applicant: Wilshire Medical Products.

Clearance details

Applicant: Wilshire Medical Products
Product code: Code MGQ
Advisory panel: Unknown
Date received: 1994-12-09
Decision date: 1995-02-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dallas, TX, US

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Adverse events under product code MGQ

product code MGQ

Death: 16
Total: 16

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.