Cleared Traditional

K946030 - DERMASSIST(TM) HYDROGEL SATURATED GAUZE DRESSING

K946030 · Wilshire Medical Products · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1995
Decision
80d
Days
-
Risk

K946030 is an FDA 510(k) clearance for the DERMASSIST(TM) HYDROGEL SATURATED GAUZE DRESSING. Classified as Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic (product code MGQ).

Submitted by Wilshire Medical Products (Dallas, US). The FDA issued a Cleared decision on February 27, 1995 after a review of 80 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 Wilshire Medical Products devices

FDA 510(k) Submission Details - K946030

510(k) Number K946030 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 09, 1994
Decision Date February 27, 1995
Days to Decision 80 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
35d faster than avg
Panel avg: 115d · This submission: 80d
Pathway characteristics
Predicate-based equivalence.

MGQ Device Classification - Class 0,

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 91
Devices cleared under the same product code (MGQ) and FDA review panel - the closest regulatory comparables to K946030.
DERMAGRAN WENT DRESSING (DEXTROSE-SALINE)
K954741 · Derma Sciences, Inc. · Nov 1995
DEROYAL WOUND CARE MULTIDEX GEL WOUND DRESSING
K952775 · Deroyal Industries, Inc. · Oct 1995
A GEL WOUND DRESSING
K951862 · Polymedica Industries, Inc. · Jul 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