Cleared Traditional

K853742 - GAUZE SPONGE

K853742 is an FDA 510(k) clearance for GAUZE SPONGE, manufactured by South Mountain Medical. The device is a Class 1 General & Plastic Surgery device with product code GDY cleared through the Traditional 510(k) pathway after a 32-day FDA review.

K853742 · South Mountain Medical · General & Plastic Surgery device
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Oct 1985
Decision
32d
Days
Class 1
Risk

K853742 is an FDA 510(k) clearance for the GAUZE SPONGE. Classified as Gauze/sponge, Internal, X-ray Detectable (product code GDY), Class I - General Controls.

Submitted by South Mountain Medical (Asheville, US). The FDA issued a Cleared decision on October 8, 1985 after a review of 32 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 South Mountain Medical devices

FDA 510(k) Submission Details - K853742

510(k) Number K853742 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 06, 1985
Decision Date October 08, 1985
Days to Decision 32 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
83d faster than avg
Panel avg: 115d · This submission: 32d
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 K853742.
QUALTEX NEUROLOK SURGICAL SPONGE
K884790 · Deroyal Industries, Inc. · Dec 1988
MODIFIED ROUND (BEEHIVE) DISSECTOR 3/8
K873391 · Ormed Mfg., Inc. · Sep 1987
DISPOSABLE LASER SPONGE SURGIMEDICS, 902001-000
K863089 · Lifestream Int'L, Inc. · Oct 1986
GAUZE & LAB SPONGES STERILE & NON
K842572 · Ulti-Med Intl., Inc. · Aug 1984
NEURO SPONGE
K840541 · Surgicot, Inc. · Apr 1984
FLORET FOAM PREP SPONGE
K833626 · Ritmed, Inc. · Feb 1984