Cleared Traditional

K961085 - DEROYAL WOUND CARE MULTIDEX PLUS GEL WOUND DRESSING

K961085 · Debusk Knitting Mills, Div. Deroyal Industries · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
May 1996
Decision
63d
Days
-
Risk

K961085 is an FDA 510(k) clearance for the DEROYAL WOUND CARE MULTIDEX PLUS GEL WOUND DRESSING. Classified as Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic (product code MGQ).

Submitted by Debusk Knitting Mills, Div. Deroyal Industries (Powell, US). The FDA issued a Cleared decision on May 21, 1996 after a review of 63 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 Debusk Knitting Mills, Div. Deroyal Industries devices

FDA 510(k) Submission Details - K961085

510(k) Number K961085 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 19, 1996
Decision Date May 21, 1996
Days to Decision 63 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
52d faster than avg
Panel avg: 115d · This submission: 63d
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 87
Devices cleared under the same product code (MGQ) and FDA review panel - the closest regulatory comparables to K961085.
WOUND HYDROGEL & STERILE WOUND HYDROGEL
K961766 · Renaissance Pharmaceutical, Inc. · Jul 1996
CARASYN HYDROGEL WOUND PRODUCTS
K961758 · Carrington Laboratories, Inc. · Jul 1996
MPM HYDROGEL DRESSING (NON-STERILE)
K962160 · Mpm Medical., Inc. · Jun 1996
BURN-AID HYDROGEL,BURN DRESSING,BURN BLANKET
K961067 · Medtrak Intl., Inc. · May 1996
CARRASYN HYDROGEL WOUND DRESSING/FDG PADS/CARAGAUZE STRIPS/PADS (MODIFICATION)
K960428 · Carrington Laboratories, Inc. · Mar 1996
BURNAID BURN FIRST AID DRESSING
K953505 · Rye Pharmaceuticals Pty. , Ltd. · Feb 1996