Diagnostic Ultrasound/Uro-GYN UDS 1002

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K902692 ↗

FDA Product Code

FAP

Device Class

Class II

Regulation

21 CFR Part 876.1620

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• Bladdermanager Pci 5000 Model 1002

  Class II

  FDA 510(k) K982568 Active Cleared 25 Jan 1999

• Diagnostic Ultrasound/Uro-Gyn Ud 511

  Class II

  FDA 510(k) K911166 Active Cleared 15 Aug 1991

• Bladder Manager PCI 5000, BladderScan BVI 5000

  Class II

  FDA 510(k) K963585 Active Cleared 1 Oct 1996

• Diagnostic Ultrasound 105 & 110

  Class II

  FDA 510(k) K842539 Active Cleared 10 Apr 1985

• Bladderscan Bvi 5000

  Class II

  FDA 510(k) K955942 Active Cleared 15 Mar 1996

• Diagnostic Ultrasound/Uro-Gyn Ups 2020

  Class II

  FDA 510(k) K911125 Active Cleared 15 Aug 1991

See all devices from Diagnostic Ultrasound Corp. →

• What is the Diagnostic Ultrasound/Uro-GYN UDS 1002 used for?

  The UDS 1002 is a cystometric gas (carbon-dioxide) on hydraulic device designed for diagnostic ultrasound procedures specifically in uro-gyn applications, used in gastroenterology and urology practices.

• How is the UDS 1002 device supplied and what sizes are available?

  The device is supplied in various sizes as indicated by the model number UDS 1002. The specific size options would be determined by the model number selected for purchase.

• What is the regulatory status of the Diagnostic Ultrasound/Uro-GYN UDS 1002?

  The UDS 1002 received FDA 510(k) clearance with number K902692 on September 13, 1990. It is classified as a Class II medical device under product code FAP and is substantially equivalent to predicate devices.

• Is the UDS 1002 device single-use or reusable?

  The device data does not specify whether the UDS 1002 is designed for single-use or multiple uses. This information would need to be obtained directly from the manufacturer or product documentation.