Cleared Traditional

K903358 - ADVANCE LAPAROTOMY SPONGE, LAP SPONGE

K903358 is an FDA 510(k) clearance for ADVANCE LAPAROTOMY SPONGE, manufactured by Advance Medical Designs, Inc.. The device is a Class 1 General & Plastic Surgery device with product code GDY cleared through the Traditional 510(k) pathway after a 126-day FDA review.

K903358 · Advance Medical Designs, Inc. · General & Plastic Surgery device
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Nov 1990
Decision
126d
Days
Class 1
Risk

K903358 is an FDA 510(k) clearance for the ADVANCE LAPAROTOMY SPONGE, LAP SPONGE. Classified as Gauze/sponge, Internal, X-ray Detectable (product code GDY), Class I - General Controls.

Submitted by Advance Medical Designs, Inc. (Marietta, US). The FDA issued a Cleared decision on November 29, 1990 after a review of 126 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.

FDA 510(k) Submission Details - K903358

510(k) Number K903358 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 26, 1990
Decision Date November 29, 1990
Days to Decision 126 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
11d slower than avg
Panel avg: 115d · This submission: 126d
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 107
Devices cleared under the same product code (GDY) and FDA review panel - the closest regulatory comparables to K903358.
SIMPEX INC. SURGICAL DRESSING
K913794 · Simpex, Inc. · Nov 1991
ICAN K DISSECTOR SPONGES
K914083 · Icn Pharmaceuticals, Inc. · Oct 1991
LAPAROTOMY SPONGES
K905135 · American Healthcare Corp. · Mar 1991
X-RAY DETECTABLE GAUZE SPONGE
K895372 · Keilei Intl., Inc. · Nov 1989
MASCOT LAB SPONGE
K894984 · Mascot, Inc. · Sep 1989
QUALTEX NEUROLOK SURGICAL SPONGE
K884790 · Deroyal Industries, Inc. · Dec 1988
K903358 · ADVANCE LAPAROTOMY SPONGE, LAP SPONGE
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