Cleared Traditional

K954738 - DERMAGRAN HYDROPHILIC WOUND DRESSING

K954738 · Derma Sciences, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K954738

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
98d faster than avg
Panel avg: 115d · This submission: 17d
Pathway characteristics
Predicate-based equivalence.

MGP Device Classification - Class 0,

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

Regulatory Peers - MGP Dressing, Wound And Burn, Occlusive

All 20
Devices cleared under the same product code (MGP) and FDA review panel - the closest regulatory comparables to K954738.
SIMPLICARE THIN FILM WOUND DRESSINGS
K980209 · Hollister, Inc. · Feb 1998
3M TEGADERM TRANSPARENT DRESSING, 3M TEGADERM TRANSPARENT DRESSING (FIRST AID DELIVERY), 3M TEGADERM HP TRANSPARENT DRES
K973036 · 3M Healthcare · Nov 1997
EPIVIEW
K961319 · Convatec, A Division of E.R. Squibb & Sons · Jul 1996
TECNOL ISLAND WOUND DRESSING
K954033 · Tecnol Medical Products, Inc. · Sep 1995
TECNOL TRANSPARENT WOUND DRESSING
K952504 · Tecnol Medical Products, Inc. · Jul 1995
ULTEC THIN HYDROCOLLOID DRESSING
K952071 · Sherwood Medical Co. · Jun 1995