Cleared Traditional

K800021 - NON ADHERANT NEUROLOGICAL SPONGES

K800021 · American Medical Disposable, Inc. · General & Plastic Surgery device
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Jan 1980
Decision
13d
Days
-
Risk

K800021 is an FDA 510(k) clearance for the NON ADHERANT NEUROLOGICAL SPONGES. Classified as Gauze/sponge, Internal (product code EFQ).

Submitted by American Medical Disposable, Inc. (Walker, US). The FDA issued a Cleared decision on January 17, 1980 after a review of 13 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 American Medical Disposable, Inc. devices

FDA 510(k) Submission Details - K800021

510(k) Number K800021 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 04, 1980
Decision Date January 17, 1980
Days to Decision 13 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
102d faster than avg
Panel avg: 115d · This submission: 13d
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 48
Devices cleared under the same product code (EFQ) and FDA review panel - the closest regulatory comparables to K800021.
STERILE GUAZE SWABS CAT.#301-420
K802022 · Pollak (Intl.), Ltd. · Sep 1980
STORZ SUPER SORB MICRO EYE SPONGE
K800082 · Storz Instrument Co. · Feb 1980
NON ADHERANT WOUND BANDAGES
K800020 · American Medical Disposable, Inc. · Jan 1980
STERILIZATION PROCESS/VAGINAL SPONGE
K792628 · Procter & Gamble Mfg. Co. · Jan 1980
TRACHEOTOMY SPONGE, W/NON-WOVEN NYLON
K792612 · American Medical Disposable, Inc. · Jan 1980
TRACHEOTOMY SPONGE, NON-ADHERENT
K792613 · American Medical Disposable, Inc. · Jan 1980