Omnicath Implanted Catheter and Depot

No FDA recalls found in the data synced 12 Oct 2026.

510(k) Number

K911775 ↗

FDA Product Code

KXK

Device Class

Class II

Regulation

21 CFR Part 892.5730

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

• Omnitron GYN Applicator System

  Class II

  FDA 510(k) K913908 Active Cleared 6 Mar 1992

• Omnitron Needle Applicators 18 and 21 Gauge

  Class II

  FDA 510(k) K920431 Active Cleared 29 May 1992

• Ir-192 Implant -- Modification

  Class II

  FDA 510(k) K923130 Active Cleared 21 Sep 1992

• Pulmocath Intrabronchial Catheter

  Class II

  FDA 510(k) K901615 Active Cleared 27 Nov 1992

• Ir-192 Implant, Modification

  Class II

  FDA 510(k) K915253 Active Cleared 27 Feb 1992

• Omnitron Remote Controlled Radionuclide Applicator

  Class II

  FDA 510(k) K881665 Active Cleared 11 Aug 1988