Cleared Traditional

K802860 - POST OP. SPONGES STERILE

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.

View all Abco Dealers, Inc. devices

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
86d faster than avg
Panel avg: 115d · This submission: 29d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EFQ Gauze/sponge, Internal
Device Class -

Regulatory Peers - EFQ Gauze/sponge, Internal

All 22
Devices cleared under the same product code (EFQ) and FDA review panel - the closest regulatory comparables to K802860.
STERILE LAPAROTOMY GAUZE SPONGE
K862126 · Anago, Inc. · Jun 1986
NU-GAUZE SPONGE
K821150 · Johnson & Johnson Professionals, Inc. · Aug 1982
SOFTCARE BARRIER WET DRESSING
K812736 · The Kendal Co. · Nov 1981
COMBINATION PADS STERILE SINGLES
K802861 · Abco Dealers, Inc. · Dec 1980
GAUZE PADS STERILE SINGLES
K802862 · Abco Dealers, Inc. · Dec 1980
GAUZE SPONGES
K802863 · Abco Dealers, Inc. · Dec 1980