510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K921839Substantially Equivalent

Entrac Ureteral Balloon Dilation Catheters

American Medical Systems, Inc., Minnetonka MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K921839 is the FDA 510(k) clearance record for ENTRAC URETERAL BALLOON DILATION CATHETERS, a class II device, cleared for American Medical Systems, Inc. on under FDA product code EZN (Dilator, Catheter, Ureteral). FDA records list 82 510(k) clearances for American Medical Systems, Inc., from to . As of , FDA records show no recalls naming K921839.

Clearance record

Decision date
Received
(194 days to decision)
Product code
EZN Dilator, Catheter, Ureteral
Regulation
21 CFR 876.5470
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
American Medical Systems, Inc. 11001 Bren Rd. E., Minnetonka MN
510(k) summary
Summary
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