510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
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K834503Substantially Equivalent

Profile Urodynamic Monitoring Sys

Browne Medical, Inc., Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K834503 is the FDA 510(k) clearance record for PROFILE URODYNAMIC MONITORING SYS, a class II device, cleared for Browne Medical, Inc. on under FDA product code FAP (Cystometric Gas (Carbon-Dioxide) On Hydraulic Device). FDA records list 4 510(k) clearances for Browne Medical, Inc., from to . As of , FDA records show no recalls naming K834503.

Clearance record

Decision date
Received
(62 days to decision)
Product code
FAP Cystometric Gas (Carbon-Dioxide) On Hydraulic Device
Regulation
21 CFR 876.1620
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Browne Medical, Inc. 4221 Richmond Rd., NW, Walker MI
Third party review
No

Clearances, product code FAP

Trailing 12 months

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

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