Cleared Traditional

NON ADHERANT WOUND BANDAGES (K800020) - FDA 510(k) Clearance

K800020 · American Medical Disposable, Inc. · General & Plastic Surgery device
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Jan 1980
Decision
13d
Days
-
Risk

K800020 is an FDA 510(k) clearance for the NON ADHERANT WOUND BANDAGES. Classified as Gauze/sponge, Internal (product code EFQ).

Submitted by American Medical Disposable, Inc. (Mchenry, 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

Submission Details

510(k) Number K800020 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
Regulatory Context
Review time vs. panel average
102d faster than avg
Panel avg: 115d · This submission: 13d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EFQ Gauze/sponge, Internal
Device Class -