Cleared Traditional

K952775 - DEROYAL WOUND CARE MULTIDEX GEL WOUND D...

K952775 · Deroyal Industries, Inc. · General & Plastic Surgery device
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Oct 1995
Decision
112d
Days
-
Risk

K952775 is an FDA 510(k) clearance for the DEROYAL WOUND CARE MULTIDEX GEL WOUND DRESSING. Classified as Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic (product code MGQ).

Submitted by Deroyal Industries, Inc. (Powell, US). The FDA issued a Cleared decision on October 6, 1995 after a review of 112 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Deroyal Industries, Inc. devices

Submission Details

510(k) Number K952775 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received June 16, 1995
Decision Date October 06, 1995
Days to Decision 112 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
3d faster than avg
Panel avg: 115d · This submission: 112d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code MGQ Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic
Device Class -

Regulatory Peers - MGQ Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic

All 15
Devices cleared under the same product code (MGQ) and FDA review panel - the closest regulatory comparables to K952775.
SOLOSITE GEL CONFORMABLE DRESSING
K981150 · Smith & Nephew, Inc. · Jun 1998
B. BRAUN MEDICAL INC. TRANSORBENT AND THINSITE BORDER DRESSING
K970453 · B.Braun Medical, Inc. · Apr 1997
AQUAFLO BTP HYDROGEL WOUND DRESSING
K952938 · Sherwood Medical Co. · Dec 1995
CURAFIL WOUND GEL DRESSING
K943073 · Kendall Healthcare Products Co. Div.Of Tyco Health · Jul 1994
BIOLEX IMPREGNATED WOUND DRESSING
K935096 · C.R. Bard, Inc. · Feb 1994
DUODERM IMPROVED CGF CONTROL GEL FORMULA DRESSING
K932101 · Convatec, A Division of E.R. Squibb & Sons · Dec 1993