Cleared Traditional

K963724 - GAUZE SPONGE, NON X-RAY DETECTABLE

K963724 · Grand Medical Products · General & Plastic Surgery device
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Nov 1996
Decision
74d
Days
-
Risk

K963724 is an FDA 510(k) clearance for the GAUZE SPONGE, NON X-RAY DETECTABLE. Classified as Gauze/sponge, Internal (product code EFQ).

Submitted by Grand Medical Products (Schaumburg, US). The FDA issued a Cleared decision on November 29, 1996 after a review of 74 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 Grand Medical Products devices

FDA 510(k) Submission Details - K963724

510(k) Number K963724 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received September 16, 1996
Decision Date November 29, 1996
Days to Decision 74 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
41d faster than avg
Panel avg: 115d · This submission: 74d
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 156
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SIMAR, INC. SURGICAL DRESSING
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GAUZE COMPRESS
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DRAIN/SLIT SPONGE (NON-STERILE AND STERILE)
K963188 · Codi International BV · Oct 1996
SURGICADE GAUZE SPONGE
K962972 · Accunex Canada,Inc. · Oct 1996