Cleared Traditional

K941522 - STERILE X-RAY DETECTABLE GAUZE SPONGES

K941522 is an FDA 510(k) clearance for STERILE X-RAY DETECTABLE GAUZE SPONGES, manufactured by Cush Medical Products. The device is a Class 1 General & Plastic Surgery device with product code GDY cleared through the Traditional 510(k) pathway after a 43-day FDA review.

K941522 · Cush Medical Products · General & Plastic Surgery device
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May 1994
Decision
43d
Days
Class 1
Risk

K941522 is an FDA 510(k) clearance for the STERILE X-RAY DETECTABLE GAUZE SPONGES. Classified as Gauze/sponge, Internal, X-ray Detectable (product code GDY), Class I - General Controls.

Submitted by Cush Medical Products (Piney Flats, US). The FDA issued a Cleared decision on May 12, 1994 after a review of 43 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 Cush Medical Products devices

FDA 510(k) Submission Details - K941522

510(k) Number K941522 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 30, 1994
Decision Date May 12, 1994
Days to Decision 43 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
72d faster than avg
Panel avg: 115d · This submission: 43d
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 22
Devices cleared under the same product code (GDY) and FDA review panel - the closest regulatory comparables to K941522.
ULTRACELL ORTHOPEDIC SPONGES
K950373 · Ultracell Medical Technologies, Inc. · Apr 1995
ULTRACELL RETRACTOR COVERS
K950659 · Ultracell Medical Technologies, Inc. · Apr 1995
LAP SPONGE PRODUCT LINE
K941344 · Cush Medical Products · May 1994
STERILE LAPAROTOMY SPONGES
K934971 · Medsurg Industries, Inc. · Feb 1994
SPECIALTY SPONGES
K920355 · Ultracell Medical Technologies, Inc. · Aug 1992
SURGICAL SPONGES
K920356 · Ultracell Medical Technologies, Inc. · Aug 1992