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.

View all Dumex Medical Surgical Products, Ltd. devices

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
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 141
Devices cleared under the same product code (EFQ) and FDA review panel - the closest regulatory comparables to K946326.
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OREX
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ISOLYSER
K940765 · Thantex Specialties, Inc. · Dec 1994
LORREX IV SPONGES, STERILE 2'S
K942824 · Lorrex Health Products · Aug 1994