Cleared Traditional

STERILE AND NON-STERILE GAUZE SPONGES (K922055) - FDA 510(k) Clearance

K922055 · Team Mfg., Inc. · General & Plastic Surgery device
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Aug 1992
Decision
98d
Days
-
Risk

K922055 is an FDA 510(k) clearance for the STERILE AND NON-STERILE GAUZE SPONGES. Classified as Gauze/sponge, Internal (product code EFQ).

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. 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

Submission Details

510(k) Number K922055 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.

Device Classification

Product Code EFQ Gauze/sponge, Internal
Device Class -

Regulatory Peers - EFQ Gauze/sponge, Internal

All 270
Devices cleared under the same product code (EFQ) and FDA review panel - the closest regulatory comparables to K922055.
ABSORBENT GAUZE ROLL
K885143 · Smith & Nephew, Inc. · Feb 1989
GAUZE SWABS, NON-STERILE
K885142 · Smith & Nephew, Inc. · Jan 1989
JOHNSON & JOHNSON FLUFF SPONGE
K881222 · Johnson & Johnson Professionals, Inc. · Mar 1988
AQUATULLE FINE MESH NON-ADHERING DRESSING
K872759 · Smith & Nephew, Inc. · Sep 1987
NU-GAUZE SPONGE
K821150 · Johnson & Johnson Professionals, Inc. · Aug 1982