510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K905375Substantially Equivalent

Accent Dg Balloon Ureteral Dilator Set

Cook Incorporated, Spencer IN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K905375 is the FDA 510(k) clearance record for ACCENT DG BALLOON URETERAL DILATOR SET, a class II device, cleared for Cook Urological, Inc. on under FDA product code EZN (Dilator, Catheter, Ureteral). FDA records list 279 510(k) clearances for Cook Incorporated, from to . As of , FDA records show no recalls naming K905375.

Clearance record

Decision date
Received
(133 days to decision)
Product code
EZN Dilator, Catheter, Ureteral
Regulation
21 CFR 876.5470
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Cook Urological, Inc. 1100 W. Morgan St., Spencer IN
Third party review
No

Clearances, product code EZN

Trailing 12 months

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

FDA records show no clearances under product code EZN in the twelve months to November 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code EZN, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260