Cleared Traditional

K801999 - GUAZE BALLS CAT.#601-720

K801999 · Pollak (Intl.), Ltd. · General & Plastic Surgery device
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Sep 1980
Decision
27d
Days
-
Risk

K801999 is an FDA 510(k) clearance for the GUAZE BALLS CAT.#601-720. 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 K801999 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
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