Cleared Traditional

K922054 - STERILE GAUZE SPONGES X-RAY DETECTABLE

K922054 is an FDA 510(k) clearance for STERILE GAUZE SPONGES X-RAY DETECTABLE, manufactured by Team Mfg., Inc.. The device is a Class 1 General & Plastic Surgery device with product code GDY cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K922054 · Team Mfg., Inc. · General & Plastic Surgery device
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Aug 1992
Decision
98d
Days
Class 1
Risk

K922054 is an FDA 510(k) clearance for the STERILE GAUZE SPONGES X-RAY DETECTABLE. Classified as Gauze/sponge, Internal, X-ray Detectable (product code GDY), Class I - General Controls.

Submitted by Team Mfg., Inc. (Augusta, US). The FDA issued a Cleared decision on August 10, 1992 after a review of 98 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 Team Mfg., Inc. devices

FDA 510(k) Submission Details - K922054

510(k) Number K922054 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 04, 1992
Decision Date August 10, 1992
Days to Decision 98 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
17d faster than avg
Panel avg: 115d · This submission: 98d
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 K922054.
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