510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K914111Substantially Equivalent

Metal Ureteral Basket Stone Dislodger, Helical

Annex Medical, Inc., Eden Prairie MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K914111 is the FDA 510(k) clearance record for METAL URETERAL BASKET STONE DISLODGER, HELICAL, a class II device, cleared for Annex Medical, Inc. on under FDA product code FGO (Dislodger, Stone, Flexible). FDA records list 23 510(k) clearances for Annex Medical, Inc., from to . As of , FDA records show no recalls naming K914111.

Clearance record

Decision date
Received
(168 days to decision)
Product code
FGO Dislodger, Stone, Flexible
Regulation
21 CFR 876.4680
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Annex Medical, Inc. 7887 Fuller Rd. #109, Eden Prairie MN
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