Cleared Traditional

K960615 - GAUZE COMPRESS

K960615 · Certified Safety Mfg., Inc. · General & Plastic Surgery device
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Nov 1996
Decision
286d
Days
-
Risk

K960615 is an FDA 510(k) clearance for the GAUZE COMPRESS. Classified as Gauze/sponge, Internal (product code EFQ).

Submitted by Certified Safety Mfg., Inc. (Kansas City, US). The FDA issued a Cleared decision on November 25, 1996 after a review of 286 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K960615

510(k) Number K960615 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received February 13, 1996
Decision Date November 25, 1996
Days to Decision 286 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
171d slower than avg
Panel avg: 115d · This submission: 286d
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 K960615.
DUKAL ABD COMBINE PAD
K970457 · Dukal Corp. · May 1997
SIMAR, INC. SURGICAL DRESSING
K970020 · Simar, Inc. · Mar 1997
GAUZE SPONGE, NON X-RAY DETECTABLE
K963724 · Grand Medical Products · Nov 1996
DRAIN/SLIT SPONGE (NON-STERILE AND STERILE)
K963188 · Codi International BV · Oct 1996
SURGICADE GAUZE SPONGE
K962972 · Accunex Canada,Inc. · Oct 1996
DRAIN/SLIT SPONGE (NON-STERILE AND STERILE)
K963134 · Igenics, Inc. · Sep 1996
K960615 · GAUZE COMPRESS
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