Cleared Traditional

K913303 - LAP SPONGES, MODIFIED

K913303 is an FDA 510(k) clearance for LAP SPONGES, manufactured by Carwild Corp.. The device is a Class 1 General & Plastic Surgery device with product code GDY cleared through the Traditional 510(k) pathway after a 378-day FDA review.

K913303 · Carwild Corp. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1992
Decision
378d
Days
Class 1
Risk

K913303 is an FDA 510(k) clearance for the LAP SPONGES, MODIFIED. Classified as Gauze/sponge, Internal, X-ray Detectable (product code GDY), Class I - General Controls.

Submitted by Carwild Corp. (Old Mystic, US). The FDA issued a Cleared decision on August 6, 1992 after a review of 378 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Carwild Corp. devices

FDA 510(k) Submission Details - K913303

510(k) Number K913303 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 25, 1991
Decision Date August 06, 1992
Days to Decision 378 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
263d slower than avg
Panel avg: 115d · This submission: 378d
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 58
Devices cleared under the same product code (GDY) and FDA review panel - the closest regulatory comparables to K913303.
SPECIALTY SPONGES
K935881 · Mcneil Healthcare, Inc. · Jan 1994
TONSIL SPONGES
K935882 · Mcneil Healthcare, Inc. · Jan 1994
X-RAY PACKING SPONGE
K935910 · Mcneil Healthcare, Inc. · Jan 1994
SPECIALTY SPONGES
K920355 · Ultracell Medical Technologies, Inc. · Aug 1992
SURGICAL SPONGES
K920356 · Ultracell Medical Technologies, Inc. · Aug 1992
SUAN FLAT DISSECTOR SPONGES
K914082 · Icn Pharmaceuticals, Inc. · Nov 1991