Cleared Traditional

K812554 - TOMAC STERILE DISP. LAP SPONGE

K812554 is the FDA 510(k) clearance for TOMAC STERILE DISP. LAP SPONGE by American Convertors Div., American Pharmaseal. It is a Class 1 General & Plastic Surgery device (product code GDY) cleared through the Traditional 510(k) pathway after a 16-day FDA review.

K812554 · American Convertors Div., American Pharmaseal · General & Plastic Surgery device
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Sep 1981
Decision
16d
Days
Class 1
Risk

K812554 is an FDA 510(k) clearance for the TOMAC STERILE DISP. LAP SPONGE. Classified as Gauze/sponge, Internal, X-ray Detectable (product code GDY), Class I - General Controls.

Submitted by American Convertors Div., American Pharmaseal (Mchenry, US). The FDA issued a Cleared decision on September 24, 1981 after a review of 16 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 American Convertors Div., American Pharmaseal devices

Submission Details

510(k) Number K812554 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 08, 1981
Decision Date September 24, 1981
Days to Decision 16 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
99d faster than avg
Panel avg: 115d · This submission: 16d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 13
Devices cleared under the same product code (GDY) and FDA review panel - the closest regulatory comparables to K812554.
POLYESTER X-RAY DETECTABLE STRUNG-SPONGE
K830201 · American Medical Disposable, Inc. · Feb 1983
COTTON BALLS, X-RAY OPAQUED STRUNG & NON
K830202 · American Medical Disposable, Inc. · Feb 1983
X-RAY DETECTABLE LAP SPONGES
K812651 · Procter & Gamble Mfg. Co. · Oct 1981
GAUZE SPONGES
K803188 · Abco Dealers, Inc. · Jan 1981
STERILIZATION PROCESS/X-RAY DETECT. SPG
K792630 · Procter & Gamble Mfg. Co. · Jan 1980
SOF-WICKLAP PAD
K780718 · Johnson & Johnson Professionals, Inc. · Jun 1978