Cleared Traditional

DEROYAL WOUND CARE MULTIDEX PLUS GEL WOUND DRESSING (K961085) - FDA 510(k) Clearance

K961085 · Debusk Knitting Mills, Div. Deroyal Industries · General & Plastic Surgery device
Download Printable Device Report (PDF)
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

Submission Details

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
Regulatory Context
Review time vs. panel average
52d faster than avg
Panel avg: 115d · This submission: 63d
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 144
Devices cleared under the same product code (MGQ) and FDA review panel - the closest regulatory comparables to K961085.
TENDERWET ACTIVE
K040517 · Medline Industries, Inc. · Mar 2004
MEDLINE TENDER WET WOUND DRESSING
K991755 · Medline Industries, Inc. · Apr 2000
SOLOSITE GEL CONFORMABLE DRESSING
K981150 · Smith & Nephew, Inc. · Jun 1998
BIOLEX IMPREGNATED WOUND DRESSING
K935096 · C.R. Bard, Inc. · Feb 1994