510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K191061Substantially Equivalent

Optilume Basic Urological Balloon Dilation Catheter

Urotronic Inc, Minneapolis MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K191061 is the FDA 510(k) clearance record for Optilume Basic Urological Balloon Dilation Catheter, a class II device, cleared for Urotronic, Inc. on under FDA product code KOE (Dilator, Urethral). FDA records list 2 510(k) clearances for Urotronic, Inc., from to . As of , FDA records show no recalls naming K191061.

Clearance record

Decision date
Received
(255 days to decision)
Product code
KOE Dilator, Urethral
Regulation
21 CFR 876.5520
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Urotronic, Inc. 2495 Xenium Ln. N, Minneapolis MN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code KOE

Trailing 12 months

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

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