Cleared Traditional

K940358 - X-LARGE MULTI-FUNCTION TRAUMA DRESSING

K940358 · Certified Safety Mfg., Inc. · General & Plastic Surgery device
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Mar 1994
Decision
57d
Days
-
Risk

K940358 is an FDA 510(k) clearance for the X-LARGE MULTI-FUNCTION TRAUMA DRESSING. Classified as Gauze/sponge, Internal (product code EFQ).

Submitted by Certified Safety Mfg., Inc. (Kansas City, US). The FDA issued a Cleared decision on March 23, 1994 after a review of 57 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 - K940358

510(k) Number K940358 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 25, 1994
Decision Date March 23, 1994
Days to Decision 57 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
58d faster than avg
Panel avg: 115d · This submission: 57d
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 192
Devices cleared under the same product code (EFQ) and FDA review panel - the closest regulatory comparables to K940358.
PLAIN GAUZE DRESSING
K940692 · Medtrax Industries, Inc. · Apr 1994
KITTNER DISSECTOR/PEANUT/CHERRY/STICK/TRIANGLE SPONGE/GAUZE ROSEBUD
K940904 · Medical Insights, Inc. · Apr 1994
NON-WOVEN SPONGE
K940901 · Medical Insights, Inc. · Mar 1994
STERILE GAUZE SPONGES
K936216 · Dav-Mar Medical Products, Inc. · Mar 1994
DUKAL NON-WOVEN GAUZE
K940440 · Dukal Corp. · Mar 1994
VISITEC EYE PAD
K940210 · Visitec Co. · Mar 1994
K940358 · X-LARGE MULTI-FUNCTION TRAUMA DRESSING
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