Transanal Endoscopic Microsurgery (Tem) Combination System and Instrument Set, Instrument Set for the Transanal Endoscop

• • Terminated Z-2706-2020 FDA Class II ·initiated 5 Jun 2020

  Tube material of a smaller diameter was used.

• • Terminated Z-1868-2018 FDA Class II ·initiated 11 Mar 2018

  Tube ends may be mixed up.

• • Terminated Z-1430-06 FDA Unclassified (pre-2012) ·initiated 7 Jul 2006

  The irrigation tubing in the tube set was assembled incorrectly with the connectors reversed.

510(k) Number

K000180 ↗

FDA Product Code

HIF

Device Class

Class II

Regulation

21 CFR Part 884.1730

Advisory Committee

Obstetrics/Gynecology

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

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