510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K921295Substantially Equivalent

Intravenous Catheters Modifications

Critikon Company, LLC, Tampa FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K921295 is the FDA 510(k) clearance record for INTRAVENOUS CATHETERS MODIFICATIONS, a class II device, cleared for Critikon Company, LLC on under FDA product code FGO (Dislodger, Stone, Flexible). FDA records list 51 510(k) clearances for Critikon Company, LLC, from to . As of , FDA records show no recalls naming K921295.

Clearance record

Decision date
Received
(431 days to decision)
Product code
FGO Dislodger, Stone, Flexible
Regulation
21 CFR 876.4680
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Critikon Company, LLC 4110 George Rd., Tampa FL
510(k) summary
Summary
Third party review
No

Clearances, product code FGO

Trailing 12 months

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

FDA records show no clearances under product code FGO in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code FGO, 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