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Browne Model UD-4DE

by Browne Corp. 510(k)

Active United States

510(k) K790478

Overview

The Browne Model UD-4DE is a Cystometric Gas (Carbon-Dioxide) on Hydraulic Device, classified under FDA product code FAP. This device is designed to measure bladder pressure and capacity by infusing carbon dioxide gas into the bladder while monitoring pressure responses, aiding in the assessment of urodynamic function in clinical settings.

The device is supplied as a reusable medical instrument and is intended for use in urology and gastroenterology procedures. It operates under hydraulic principles and requires regulatory compliance with FDA clearance (510(k) K790478, granted under Substantially Equivalent decision). Storage and handling follow standard sterile or non-sterile medical equipment protocols, with no explicit MRI safety restrictions noted in the data.

AI-generated from registry data, 19 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK790478 Date1 Jun 1979ClearedStatusActive

Coverage

1 jurisdiction

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  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 6 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
FAP
Device Class
Class II
Regulation
21 CFR Part 876.1620
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

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