Cleared Traditional

K960615 - GAUZE COMPRESS (FDA 510(k) Clearance)

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.

View all Certified Safety Mfg., Inc. devices

Submission Details

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
Regulatory Context
Review time vs. panel average
172d slower than avg
Panel avg: 114d · This submission: 286d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EFQ Gauze/sponge, Internal
Device Class -