Cleared Traditional

DERMAGRAN HYDROPHILIC WOUND DRESSING (K954738) - FDA 510(k) Clearance

K954738 · Derma Sciences, Inc. · General & Plastic Surgery device
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Nov 1995
Decision
17d
Days
-
Risk

K954738 is an FDA 510(k) clearance for the DERMAGRAN HYDROPHILIC WOUND DRESSING. Classified as Dressing, Wound And Burn, Occlusive (product code MGP).

Submitted by Derma Sciences, Inc. (Old Forge, US). The FDA issued a Cleared decision on November 2, 1995 after a review of 17 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 K954738 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 16, 1995
Decision Date November 02, 1995
Days to Decision 17 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
98d faster than avg
Panel avg: 115d · This submission: 17d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code MGP Dressing, Wound And Burn, Occlusive
Device Class -

Regulatory Peers - MGP Dressing, Wound And Burn, Occlusive

All 8
Devices cleared under the same product code (MGP) and FDA review panel - the closest regulatory comparables to K954738.
CICANET WOUND CONTACT LAYER DRESSING - 2 X 3 IN. MODEL 59100600, CICANET WOUND CONTACT LAYER DRESSING - 4 X 5 IN. MODEL0
K981713 · Smith & Nephew, Inc. · Jul 1998
SIMPLICARE THIN FILM WOUND DRESSINGS
K980209 · Hollister, Inc. · Feb 1998
EPIVIEW
K961319 · Convatec, A Division of E.R. Squibb & Sons · Jul 1996
ULTEC THIN HYDROCOLLOID DRESSING
K952071 · Sherwood Medical Co. · Jun 1995
CONMED VENI-GARD(TM I.V. DRESSING-PRODUCT LINE EXTENSION AND MODIFICATIONS
K950065 · Conmedcorp · Mar 1995
DEROYAL TRANSPARENT FILM DRESSIGN
K920796 · Deroyal Industries, Inc. · Jul 1992