Cleared Traditional

K960388 - DYNAREX NON-WOVEN SPONGE

K960388 · Dynarex Corp. · General & Plastic Surgery device
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Apr 1996
Decision
66d
Days
-
Risk

K960388 is an FDA 510(k) clearance for the DYNAREX NON-WOVEN SPONGE. Classified as Gauze/sponge, Internal (product code EFQ).

Submitted by Dynarex Corp. (Brewster, US). The FDA issued a Cleared decision on April 1, 1996 after a review of 66 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 - K960388

510(k) Number K960388 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 26, 1996
Decision Date April 01, 1996
Days to Decision 66 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
49d faster than avg
Panel avg: 115d · This submission: 66d
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 169
Devices cleared under the same product code (EFQ) and FDA review panel - the closest regulatory comparables to K960388.
CODI SYNTHETIC SPONGE(NON-STERILE AND STERILE)
K961061 · Codi International BV · Jun 1996
EMERALD STERILE GAUZE SPONGE
K961581 · Emerald Medical, Inc. · May 1996
NHMC DRESSING TRAY
K960523 · National Healthcare Mfg. Corp. · Apr 1996
PROTEC ROLL GAUZE
K960093 · Derivadas Degasa S.A. DE C.V. · Mar 1996
SYNTHETIC SPONGE
K955165 · Igenics, Inc. · Feb 1996
GENERAL USE SYNTHETIC SPONGE (STERILE)
K955527 · Igenics, Inc. · Feb 1996