Cleared Traditional

K905135 - LAPAROTOMY SPONGES

K905135 is the FDA 510(k) clearance for LAPAROTOMY SPONGES by American Healthcare Corp.. It is a Class 1 General & Plastic Surgery device (product code GDY) cleared through the Traditional 510(k) pathway after a 111-day FDA review.

K905135 · American Healthcare Corp. · General & Plastic Surgery device
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Mar 1991
Decision
111d
Days
Class 1
Risk

K905135 is an FDA 510(k) clearance for the LAPAROTOMY SPONGES. Classified as Gauze/sponge, Internal, X-ray Detectable (product code GDY), Class I - General Controls.

Submitted by American Healthcare Corp. (Canada, CA). The FDA issued a Cleared decision on March 6, 1991 after a review of 111 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all American Healthcare Corp. devices

Submission Details

510(k) Number K905135 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 15, 1990
Decision Date March 06, 1991
Days to Decision 111 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
4d faster than avg
Panel avg: 115d · This submission: 111d
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 7
Devices cleared under the same product code (GDY) and FDA review panel - the closest regulatory comparables to K905135.
STRYKER FEMORAL CANAL SPONGE & ACETABULUM SPONGE
K955599 · Stryker Corp. · Feb 1996
QUALTEX NEUROLOK SURGICAL SPONGE
K884790 · Deroyal Industries, Inc. · Dec 1988
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