Cleared Traditional

K951660 - DYNAREX GAUZE SPONGE

K951660 · Dynarex Corp. · General & Plastic Surgery device
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May 1995
Decision
29d
Days
-
Risk

K951660 is an FDA 510(k) clearance for the DYNAREX GAUZE SPONGE. Classified as Gauze/sponge, Internal (product code EFQ).

Submitted by Dynarex Corp. (Brewster, US). The FDA issued a Cleared decision on May 9, 1995 after a review of 29 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 Dynarex Corp. devices

FDA 510(k) Submission Details - K951660

510(k) Number K951660 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 10, 1995
Decision Date May 09, 1995
Days to Decision 29 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
86d faster than avg
Panel avg: 115d · This submission: 29d
Pathway characteristics
Predicate-based equivalence.

EFQ Device Classification - Class 0,

Product Code EFQ Gauze/sponge, Internal
Device Class -

Regulatory Peers - EFQ Gauze/sponge, Internal

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