Cleared Traditional

K802862 - GAUZE PADS STERILE SINGLES

K802862 · Abco Dealers, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1980
Decision
29d
Days
-
Risk

K802862 is an FDA 510(k) clearance for the GAUZE PADS STERILE SINGLES. 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 K802862 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 K802862.
SOFTCARE BARRIER WET DRESSING
K812736 · The Kendal Co. · Nov 1981
POST OP. SPONGES STERILE
K802860 · Abco Dealers, Inc. · Dec 1980
COMBINATION PADS STERILE SINGLES
K802861 · Abco Dealers, Inc. · Dec 1980
GAUZE SPONGES
K802863 · Abco Dealers, Inc. · Dec 1980
STORZ SUPER SORB MICRO EYE SPONGE
K800082 · Storz Instrument Co. · Feb 1980
STERILIZATION PROCESS/VAGINAL SPONGE
K792628 · Procter & Gamble Mfg. Co. · Jan 1980