Cleared Traditional

K954664 - DERMAGRAN (ZINC SALINE) HYDROGEL WOUND ...

K954664 · Derma Sciences, Inc. · General & Plastic Surgery device
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Nov 1995
Decision
22d
Days
-
Risk

K954664 is an FDA 510(k) clearance for the DERMAGRAN (ZINC SALINE) HYDROGEL WOUND DRESSING. Classified as Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic (product code MGQ).

Submitted by Derma Sciences, Inc. (Old Forge, US). The FDA issued a Cleared decision on November 1, 1995 after a review of 22 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Derma Sciences, Inc. devices

Submission Details

510(k) Number K954664 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received October 10, 1995
Decision Date November 01, 1995
Days to Decision 22 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
93d faster than avg
Panel avg: 115d · This submission: 22d
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 9
Devices cleared under the same product code (MGQ) and FDA review panel - the closest regulatory comparables to K954664.
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
DEROYAL WOUND CARE MULTIDEX GEL WOUND DRESSING
K952775 · Deroyal Industries, Inc. · Oct 1995
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