510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K922055Substantially Equivalent

Sterile and Non-Sterile Gauze Sponges

Team Mfg., Inc., Augusta GA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K922055 is the FDA 510(k) clearance record for STERILE AND NON-STERILE GAUZE SPONGES, cleared for Team Mfg., Inc. on under FDA product code EFQ (Gauze/Sponge, Internal). FDA records list 3 510(k) clearances for Team Mfg., Inc., from to . As of , FDA records show no recalls naming K922055.

Clearance record

Decision date
Received
(98 days to decision)
Product code
EFQ Gauze/Sponge, Internal
Device class
Unclassified
Review panel
Unknown
Applicant
Team Mfg., Inc. P.O. Box 15427, Augusta GA
510(k) summary
Statement
Third party review
No

Clearances, product code EFQ

Trailing 12 months

FDA records hold no clearances under product code EFQ in the trailing twelve months.

FDA records show no clearances under product code EFQ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code EFQ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260