ROYL-DERM WOUND HYDROGEL DRESSING— 510(k) K932973

Name: FDA 510(k) clearance K932973
Creator: U.S. Food and Drug Administration
Published: 1994-01-10

Substantially Equivalent

Renaissance Medical, Inc.

FDA 510(k) clearance K932973 for ROYL-DERM WOUND HYDROGEL DRESSING, Substantially Equivalent on 1994-01-10. Applicant: Renaissance Medical, Inc.. Device class: Unclassified.

Clearance details

Applicant: Renaissance Medical, Inc.
Product code: Code MGQ
Device class: Unclassified
Advisory panel: Unknown
Date received: 1993-06-14
Decision date: 1994-01-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dana Point, CA, US

Download summary PDF View on FDA.gov ↗

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K935203 — WOUND HYDROGEL AND/OR STERILE WOUND HYDROGEL1994-01-18
K933817 — ROYL-DERM WOUND HYDROGEL STERILE UNIT DOSE1994-01-10
K922815 — ROYL-DERM WOUND HYDROGEL1992-10-28

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.