Cleared Traditional

K953810 - FLUFF GAUZE BANDAGE, STERILE & NON-STERILE

K953810 · K. W. Griffen Co. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1995
Decision
37d
Days
-
Risk

K953810 is an FDA 510(k) clearance for the FLUFF GAUZE BANDAGE, STERILE & NON-STERILE. Classified as Gauze/sponge, Internal (product code EFQ).

Submitted by K. W. Griffen Co. (Norwalk, US). The FDA issued a Cleared decision on September 14, 1995 after a review of 37 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 K. W. Griffen Co. devices

FDA 510(k) Submission Details - K953810

510(k) Number K953810 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 08, 1995
Decision Date September 14, 1995
Days to Decision 37 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
78d faster than avg
Panel avg: 115d · This submission: 37d
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 157
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LESINSKI SURGICAL EAR DRESSING
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