510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K180053Substantially Equivalent

Sof-Flex Ureteral Stent Set

Cook Incorporated, Bloomington IN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K180053 is the FDA 510(k) clearance record for Sof-Flex Ureteral Stent Set, a class II device, cleared for Cook Incorporated on under FDA product code FAD (Stent, Ureteral). FDA records list 279 510(k) clearances for Cook Incorporated, from to . As of , FDA records show no recalls naming K180053.

Clearance record

Decision date
Received
(248 days to decision)
Product code
FAD Stent, Ureteral
Regulation
21 CFR 876.4620
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Cook Incorporated 750 Daniels Way, Bloomington IN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code FAD

Trailing 12 months
2 clearances under product code FAD in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code FAD, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20261
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260