Cleared Traditional

K802022 - STERILE GUAZE SWABS CAT.#301-420

K802022 · Pollak (Intl.), Ltd. · General & Plastic Surgery device
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Sep 1980
Decision
27d
Days
-
Risk

K802022 is an FDA 510(k) clearance for the STERILE GUAZE SWABS CAT.#301-420. Classified as Gauze/sponge, Internal (product code EFQ).

Submitted by Pollak (Intl.), Ltd. (Mchenry, US). The FDA issued a Cleared decision on September 16, 1980 after a review of 27 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 Pollak (Intl.), Ltd. devices

Submission Details

510(k) Number K802022 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 20, 1980
Decision Date September 16, 1980
Days to Decision 27 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
88d faster than avg
Panel avg: 115d · This submission: 27d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EFQ Gauze/sponge, Internal
Device Class -

Regulatory Peers - EFQ Gauze/sponge, Internal

All 42
Devices cleared under the same product code (EFQ) and FDA review panel - the closest regulatory comparables to K802022.
GUAZE BALLS CAT.#601-720
K801999 · Pollak (Intl.), Ltd. · Sep 1980
ABSORBENT PAD CAT.#729, 732, 730, 731
K802005 · Pollak (Intl.), Ltd. · Sep 1980
GUAZE SWABS CAT.#251-300 (SIZE & PLY)
K802010 · 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
NON ADHERANT NEUROLOGICAL SPONGES
K800021 · American Medical Disposable, Inc. · Jan 1980