Cleared Traditional

K945020 - FLUFF GAUZE SPONGE (FDA 510(k) Clearance)

K945020 · Clinical Resources, Inc. · General & Plastic Surgery device
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Dec 1994
Decision
72d
Days
-
Risk

K945020 is an FDA 510(k) clearance for the FLUFF GAUZE SPONGE. Classified as Gauze/sponge, Internal (product code EFQ).

Submitted by Clinical Resources, Inc. (Elgin, US). The FDA issued a Cleared decision on December 23, 1994 after a review of 72 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 Clinical Resources, Inc. devices

Submission Details

510(k) Number K945020 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 12, 1994
Decision Date December 23, 1994
Days to Decision 72 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
42d faster than avg
Panel avg: 114d · This submission: 72d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EFQ Gauze/sponge, Internal
Device Class -