Cleared Traditional

K980861 - DUMEX PAK-ITS COTTON GAUZE PACKING IMPREGNATED WITH HYDROGEL

K980861 · Dumex Medical Surgical Products, Ltd. · General & Plastic Surgery device
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May 1998
Decision
76d
Days
-
Risk

K980861 is an FDA 510(k) clearance for the DUMEX PAK-ITS COTTON GAUZE PACKING IMPREGNATED WITH HYDROGEL. Classified as Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic (product code MGQ).

Submitted by Dumex Medical Surgical Products, Ltd. (Toronto, Orntario, CA). The FDA issued a Cleared decision on May 20, 1998 after a review of 76 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 Dumex Medical Surgical Products, Ltd. devices

FDA 510(k) Submission Details - K980861

510(k) Number K980861 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 05, 1998
Decision Date May 20, 1998
Days to Decision 76 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
39d faster than avg
Panel avg: 115d · This submission: 76d
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 65
Devices cleared under the same product code (MGQ) and FDA review panel - the closest regulatory comparables to K980861.
PHYTACARE ALGINATE HYDROGEL WOUND DRESSING
K980132 · Phytatek Laboratories, Inc. · Jun 1998
X-CELL WOUND DRESSING
K974251 · Xylos Corporation · Jun 1998
SOLOSITE GEL CONFORMABLE DRESSING
K981150 · Smith & Nephew, Inc. · Jun 1998
FLEXIGEL-G HYDROGEL WOUND DRESSING
K980097 · Innovative Technologies , Ltd. · Mar 1998
DUODERM HYDROACTIVE GEL
K973806 · Convatec, A Bristol-Myers Squibb Co. · Dec 1997
AQUA PATCH
K973693 · Pci Technology · Dec 1997