Cleared Traditional

K922055 - STERILE AND NON-STERILE GAUZE SPONGES

K922055 · Team Mfg., Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K922055

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.

EFQ Device Classification - Class 0,

Product Code EFQ Gauze/sponge, Internal
Device Class -

Regulatory Peers - EFQ Gauze/sponge, Internal

All 157
Devices cleared under the same product code (EFQ) and FDA review panel - the closest regulatory comparables to K922055.
SURGICAL LAPAROTOMY SPONGE X-RAY DETECTABLE
K935942 · Mcneil Healthcare, Inc. · Jan 1994
DYNAREX GAUZE SPONGE OR PADS
K933308 · Dynarex Corp. · Dec 1993
NU-BREDE PACKING AND DEBRIDEMENT SPONGE
K921983 · Johnson & Johnson Medical, Inc. · Sep 1992
PTI INTRA-ART (TM) PICK-UP WICKS
K905068 · Pioneering Technologies, Inc. · Dec 1991
SERENE WRAP
K895865 · Byron Medical · Dec 1989
LAP SPONGE
K896801 · Westmark, Sterile Packing Systems, Inc. (Sps) · Dec 1989