Cleared Traditional

K946326 - DUTEX GAUZE BANDAGE

K946326 · Dumex Medical Surgical Products, Ltd. · General & Plastic Surgery device
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Jan 1995
Decision
33d
Days
-
Risk

K946326 is an FDA 510(k) clearance for the DUTEX GAUZE BANDAGE. Classified as Gauze/sponge, Internal (product code EFQ).

Submitted by Dumex Medical Surgical Products, Ltd. (Toronto, Orntario, CA). The FDA issued a Cleared decision on January 24, 1995 after a review of 33 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.

FDA 510(k) Submission Details - K946326

510(k) Number K946326 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 22, 1994
Decision Date January 24, 1995
Days to Decision 33 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
82d faster than avg
Panel avg: 115d · This submission: 33d
Pathway characteristics
Predicate-based equivalence.

EFQ Device Classification - Class 0,

Product Code EFQ Gauze/sponge, Internal
Device Class -

Regulatory Peers - EFQ Gauze/sponge, Internal

All 210
Devices cleared under the same product code (EFQ) and FDA review panel - the closest regulatory comparables to K946326.
LORREX GAUZE PADS (1'S) AND LORREX GAUZE SPONGES - STERILE 2'S AND STERILE 10'S AND NON-STERILE
K951418 · Lorons International Corp. · Apr 1995
1X6YD, 2X6YD, 4X6YD ROLL BANDAGE
K945002 · Certified Safety Mfg., Inc. · Mar 1995
2, 3 & 4 BANDADGE COMPRESS
K945004 · Certified Safety Mfg., Inc. · Mar 1995
LORREX NON-WOVEN SPONGES NON-STERILE, STERILE, DRESSINGS
K945960 · Lorons International Corp. · Jan 1995
DUFLEX CONFORMING BANDAGE (STERILE/NON-STERILE)
K945830 · Dumex Medical Surgical Products, Ltd. · Jan 1995
FLUFF GAUXZE ROLL
K945019 · Clinical Resources, Inc. · Dec 1994
K946326 · DUTEX GAUZE BANDAGE
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