Auxiliary Instruments for Urs

• 2 recalls, same reason

  • Ongoing Z-1422-2023 FDA Class II ·initiated 24 Mar 2023
  • Ongoing Z-1423-2023 FDA Class II ·initiated 24 Mar 2023

  Potentially unable to open forceps jaws when the endoscope shaft is bent by about 90 degrees. If, in addition, the proximal forceps shaft is bent, the forceps can no longer be opened or restrictions begin even with a slight bending of the endoscope.

510(k) Number

K971315 ↗

FDA Product Code

FCL

Device Class

Class I

Regulation

21 CFR Part 876.1075

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• Suction and Irrigation Tubes

  Class II

  FDA 510(k) K940960 Active Cleared 8 Nov 1994

• Needle, Spray

  Class II

  FDA 510(k) K770710 Active Cleared 26 Apr 1977

• Trocars Trotec with Automatic Protective Mechanism

  Class II

  FDA 510(k) K003164 Active Cleared 8 Jan 2001

• Resection Pump, Resectoscope for Chip Aspiration, Endoscope 25/ 3.3 Mm, Accessories

  Class II

  FDA 510(k) K042523 Active Cleared 18 Mar 2005

• Endoscopes W/Permanent and Removable Eyepiece, Panoview Plus Telescope W/Plug-on Connector

  Class II

  FDA 510(k) K972927 Active Cleared 6 Nov 1997

• Flexible Video Cystoscope/Choledochoscope, Models 7308.061 and 7308.066

  Class II

  FDA 510(k) K051176 Active Cleared 5 Oct 2005

See all devices from Richard Wolf Medical Instruments Corp. →