510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K894925Substantially Equivalent

Amcath Ureteral Dilators Models 7100,7110,7120

Intec Medical, Inc., Danielson CT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K894925 is the FDA 510(k) clearance record for AMCATH URETERAL DILATORS MODELS 7100,7110,7120, a class II device, cleared for Intec Medical, Inc. on under FDA product code EZN (Dilator, Catheter, Ureteral). FDA records list 17 510(k) clearances for Intec Medical, Inc., from to . As of , FDA records show no recalls naming K894925.

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
Intec Medical, Inc. 175 Connecticut Mills Ave., Danielson CT
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