Cleared Traditional

K802798 - OPRATEX ABDOMINAL PAD

K802798 is an FDA 510(k) clearance for OPRATEX ABDOMINAL PAD, manufactured by Secol Co.. The device is a Class 1 General & Plastic Surgery device with product code GDY cleared through the Traditional 510(k) pathway after a 37-day FDA review.

K802798 · Secol Co. · General & Plastic Surgery device
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Dec 1980
Decision
37d
Days
Class 1
Risk

K802798 is an FDA 510(k) clearance for the OPRATEX ABDOMINAL PAD. Classified as Gauze/sponge, Internal, X-ray Detectable (product code GDY), Class I - General Controls.

Submitted by Secol Co. (Mchenry, US). The FDA issued a Cleared decision on December 11, 1980 after a review of 37 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4450 - the FDA general and plastic surgery device framework. 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 Secol Co. devices

FDA 510(k) Submission Details - K802798

510(k) Number K802798 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 04, 1980
Decision Date December 11, 1980
Days to Decision 37 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
78d faster than avg
Panel avg: 115d · This submission: 37d
Pathway characteristics
Predicate-based equivalence.

GDY Device Classification - Class 1, General Controls

Product Code GDY Gauze/sponge, Internal, X-ray Detectable
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4450
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - GDY Gauze/sponge, Internal, X-ray Detectable

All 57
Devices cleared under the same product code (GDY) and FDA review panel - the closest regulatory comparables to K802798.
X-RAY DETECTABLE LAP SPONGES
K812651 · Procter & Gamble Mfg. Co. · Oct 1981
TOMAC STERILE DISP. LAP SPONGE
K812554 · American Convertors Div., American Pharmaseal · Sep 1981
GAUZE SPONGES
K803188 · Abco Dealers, Inc. · Jan 1981
CONTAIN X-RAY DETECTABLE LAP SPONGE
K801768 · The Buckeye Cellulose Corp. · Aug 1980
STERILIZATION PROCESS/X-RAY DETECT. SPG
K792630 · Procter & Gamble Mfg. Co. · Jan 1980
LAP SPONGE
K782107 · Carapace, Inc. · Feb 1979