Cleared Traditional

K802860 - POST OP. SPONGES STERILE (FDA 510(k) Clearance)

K802860 · Abco Dealers, Inc. · General & Plastic Surgery device
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Dec 1980
Decision
29d
Days
-
Risk

K802860 is an FDA 510(k) clearance for the POST OP. SPONGES STERILE. Classified as Gauze/sponge, Internal (product code EFQ).

Submitted by Abco Dealers, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 11, 1980 after a review of 29 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.

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Submission Details

510(k) Number K802860 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 12, 1980
Decision Date December 11, 1980
Days to Decision 29 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
85d faster than avg
Panel avg: 114d · This submission: 29d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EFQ Gauze/sponge, Internal
Device Class -