Cavermap Surgical Aid

• • Terminated Z-1235-03 FDA Unclassified (pre-2012) ·initiated 10 Jul 2003 ·on shared 510(k) K000507

  Product's sterility is compromised due to a failed sterility audit

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K000507 ↗

FDA Product Code

ETN

Device Class

Class II

Regulation

21 CFR Part 874.1820

Advisory Committee

Ear, Nose, Throat

FDA Decision

SESE Substantially Equivalent

• Uromed Patch

  Class I

  FDA 510(k) K974600 Active Cleared 31 Mar 1998

• Modification to Cavermap Surgical Aid

  Class I

  FDA 510(k) K010098 Active Cleared 1 Feb 2001

• Uromed Needle Grasper

  Class II

  FDA 510(k) K974137 Active Cleared 30 Jan 1998

• Uromed Sling Kit

  Class II

  FDA 510(k) K980717 Active Cleared 22 May 1998

• Uromed Alternative Bladder Control Continence Device(Abcpn-0026)

  Class I

  FDA 510(k) K971992 Active Cleared 1 Aug 1997

• Cavermap Surgical Aid

  Class I

  FDA 510(k) K993436 Active Cleared 11 Feb 2000

See all devices from Uromed Corp. →