510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K850355Substantially Equivalent

Mentor Percutaneous Renal Dilator Set

Mentor, Goleta CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K850355 is the FDA 510(k) clearance record for MENTOR PERCUTANEOUS RENAL DILATOR SET, a class II device, cleared for Mentor Corp. on under FDA product code EZN (Dilator, Catheter, Ureteral). FDA records list 65 510(k) clearances for Mentor Corp., from to . As of , FDA records show no recalls naming K850355.

Clearance record

Decision date
Received
(41 days to decision)
Product code
EZN Dilator, Catheter, Ureteral
Regulation
21 CFR 876.5470
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Mentor Corp. 600 Pine Ave., Goleta CA
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 October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code EZN, 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