Cleared Traditional

DRAIN/SLIT SPONGE (NON-STERILE AND STERILE) (K963188) - FDA 510(k) Clearance

K963188 · Codi International BV · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
Oct 1996
Decision
76d
Days
-
Risk

K963188 is an FDA 510(k) clearance for the DRAIN/SLIT SPONGE (NON-STERILE AND STERILE). Classified as Gauze/sponge, Internal (product code EFQ).

Submitted by Codi International BV (Turbinestraat 13-19, NL). The FDA issued a Cleared decision on October 30, 1996 after a review of 76 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 Codi International BV devices

Submission Details

510(k) Number K963188 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 15, 1996
Decision Date October 30, 1996
Days to Decision 76 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
39d faster than avg
Panel avg: 115d · This submission: 76d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EFQ Gauze/sponge, Internal
Device Class -

Regulatory Peers - EFQ Gauze/sponge, Internal

Devices cleared under the same product code (EFQ) and FDA review panel - the closest regulatory comparables to K963188.
ABSORBENT GAUZE ROLL
K885143 · Smith & Nephew, Inc. · Feb 1989
GAUZE SWABS, NON-STERILE
K885142 · Smith & Nephew, Inc. · Jan 1989
JOHNSON & JOHNSON FLUFF SPONGE
K881222 · Johnson & Johnson Professionals, Inc. · Mar 1988
AQUATULLE FINE MESH NON-ADHERING DRESSING
K872759 · Smith & Nephew, Inc. · Sep 1987
NU-GAUZE SPONGE
K821150 · Johnson & Johnson Professionals, Inc. · Aug 1982