510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K941105Substantially Equivalent

Uorcap,model Number Uds-Ucap

Laborie Medical Tech Corp., Mississauga, CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K941105 is the FDA 510(k) clearance record for UORCAP,MODEL NUMBER UDS-UCAP, a class II device, cleared for Laborie Medical Tech, Inc. on under FDA product code EXY (Uroflowmeter). FDA records list 6 510(k) clearances for Laborie Medical Tech, Inc., from to . As of , FDA records show no recalls naming K941105.

Clearance record

Decision date
Received
(64 days to decision)
Product code
EXY Uroflowmeter
Regulation
21 CFR 876.1800
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Laborie Medical Tech, Inc. 6415 Northwest Dr., Unit 11, Mississauga, CA
510(k) summary
Statement
Third party review
No

Clearances, product code EXY

Trailing 12 months

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

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