510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K961061Substantially Equivalent for Some Indications

Codi Synthetic Sponge(non-Sterile and Sterile)

Codi International BV, Boston MA / Traditional, Substantially Equivalent for Some Indications
FDA source (opens on fda.gov)

K961061 is the FDA 510(k) clearance record for CODI SYNTHETIC SPONGE(NON-STERILE AND STERILE), cleared for Codi International BV on under FDA product code EFQ (Gauze/Sponge, Internal). FDA records list 2 510(k) clearances for Codi International BV, from to . As of , FDA records show no recalls naming K961061.

Clearance record

Decision date
Received
(80 days to decision)
Product code
EFQ Gauze/Sponge, Internal
Device class
Unclassified
Review panel
Unknown
Applicant
Codi International BV One Beacon St., Boston MA
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