510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K082701Substantially Equivalent

Uronirs, Model 2000

Urodynamix Technologies, Ltd., Vancouver Bc, CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K082701 is the FDA 510(k) clearance record for URONIRS, MODEL 2000, a class II device, cleared for Urodynamix Technologies, Ltd. on under FDA product code FEN (Device, Cystometric, Hydraulic). FDA records list one 510(k) clearance for Urodynamix Technologies, Ltd. As of , FDA records show no recalls naming K082701.

Clearance record

Decision date
Received
(93 days to decision)
Product code
FEN Device, Cystometric, Hydraulic
Regulation
21 CFR 876.1620
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Urodynamix Technologies, Ltd. 1485-555 Burrard St., Vancouver Bc, CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code FEN

Trailing 12 months

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

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