Bladder Kit - 734000

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K772341 ↗

FDA Product Code

FCM

Device Class

Class II

Regulation

21 CFR Part 876.5130

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• Akron Male External Catheter

  Class II

  FDA 510(k) K781433 Active Cleared 3 Nov 1978

• Catheter, Akron Foley Teflon

  Class II

  FDA 510(k) K781751 Active Cleared 22 Jan 1979

• Akron Urinary Drainage Bat

  Class II

  FDA 510(k) K812058 Active Cleared 31 Jul 1981

• Bladder Retention-Cathetherizationtray

  Class II

  FDA 510(k) K772277 Active Cleared 2 Mar 1978

• Bladder Cath Kit W/Out Catheter

  Class II

  FDA 510(k) K780268 Active Cleared 24 Feb 1978

• Robinson Kit - 750014 & 750016

  Class II

  FDA 510(k) K772342 Active Cleared 24 Feb 1978

See all devices from Latex Ind., Inc. →

• What is the Bladder Kit - 734000 used for?

  The Bladder Kit - 734000 is a sterile urethral catheterization tray intended for use in urology and gastroenterology procedures. It may or may not include a catheter depending on the specific kit configuration.

• Is the Bladder Kit - 734000 single-use or reusable?

  The device is not specified as single-use or reusable in the available information. Users should refer to the specific product instructions for guidance on appropriate use and disposal.

• What regulatory approvals does the Bladder Kit - 734000 have?

  The Bladder Kit - 734000 is classified as Class II by the FDA and received 510(k) clearance with number K772341 on February 24, 1978. It is manufactured by Latex Ind., Inc. and is classified under product code FCM.

• What sizes and models of the Bladder Kit - 734000 are available?

  The available device data does not specify different sizes or models for the Bladder Kit - 734000. The product appears to be standardized as a sterile urethral catheterization tray, though it may or may not include a catheter depending on the specific kit configuration.