510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K113510Substantially Equivalent

Evolution Colonic Stent System

Cook Ireland Ltd., Limerick, IE / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K113510 is the FDA 510(k) clearance record for EVOLUTION COLONIC STENT SYSTEM, a class II device, cleared for Cook Ireland, Ltd. on under FDA product code MQR (Stent, Colonic, Metallic, Expandable). FDA records list 34 510(k) clearances for Cook Ireland, Ltd., from to . As of , FDA records show no recalls naming K113510.

Clearance record

Decision date
Received
(171 days to decision)
Product code
MQR Stent, Colonic, Metallic, Expandable
Regulation
21 CFR 878.3610
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Cook Ireland, Ltd. O'Halloran Rd., Limerick, IE
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MQR

Trailing 12 months

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

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