WOUND HYDROGEL & STERILE WOUND HYDROGEL— 510(k) K961766

Name: FDA 510(k) clearance K961766
Creator: U.S. Food and Drug Administration
Published: 1996-07-15

Substantially Equivalent for Some Indications

Renaissance Pharmaceutical, Inc.

FDA 510(k) clearance K961766 for WOUND HYDROGEL & STERILE WOUND HYDROGEL, Substantially Equivalent for Some Indications on 1996-07-15. Applicant: Renaissance Pharmaceutical, Inc.. Device class: Unclassified.

Clearance details

Applicant: Renaissance Pharmaceutical, Inc.
Product code: Code MGQ
Device class: Unclassified
Advisory panel: Unknown
Date received: 1996-05-03
Decision date: 1996-07-15
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Glenbrook, NV, US

Download summary PDF View on FDA.gov ↗

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K961316 — WOUND HYDROGEL AND/OR STERILE WOUND HYDROGEL1996-07-15
K954384 — WOUND HYDROGEL AND/OR STERILE WOUND HYDROGEL1995-10-16
K941339 — STERILE WOUND HYDROGEL DRESSING1994-06-10

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.