Cleared Traditional

K953501 - ADI STERILE GAUZE SPONGES

K953501 · Asia Dynamics, Inc. · General & Plastic Surgery device
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Aug 1995
Decision
33d
Days
-
Risk

K953501 is an FDA 510(k) clearance for the ADI STERILE GAUZE SPONGES. Classified as Gauze/sponge, Internal (product code EFQ).

Submitted by Asia Dynamics, Inc. (Niles, US). The FDA issued a Cleared decision on August 28, 1995 after a review of 33 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 Asia Dynamics, Inc. devices

FDA 510(k) Submission Details - K953501

510(k) Number K953501 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 26, 1995
Decision Date August 28, 1995
Days to Decision 33 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
82d faster than avg
Panel avg: 115d · This submission: 33d
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 157
Devices cleared under the same product code (EFQ) and FDA review panel - the closest regulatory comparables to K953501.
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K951660 · Dynarex Corp. · May 1995
1X6YD, 2X6YD, 4X6YD ROLL BANDAGE
K945002 · Certified Safety Mfg., Inc. · Mar 1995