Modification to Endoscopic Plication System

• • Terminated Z-0685-2007 FDA Unclassified (pre-2012) ·initiated 26 Jan 2007 ·on shared 510(k) K032820

  Device arm may fail to open after being deployed and require surgical intervention to remove

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

510(k) Number

K032820 ↗

FDA Product Code

ODE

Device Class

Class II

Regulation

21 CFR Part 876.1500

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• Endoscopic Plication System, Eps, Eplicator, Plicator Instrument

  Class II

  FDA 510(k) K072125 Active Cleared 18 Oct 2007

• Plicator Gsx Suturing System, Plicator Gsx, Plicator Instrument, Plicator Gsx Suture Cartridge

  Class II

  FDA 510(k) K073671 Active Cleared 26 Mar 2008

• Endoscopic Plication System, Model 160-00760

  Class II

  FDA 510(k) K031262 Active Cleared 23 May 2003

• Endoscopic Plication System; Eps; Plicator

  Class II

  FDA 510(k) K071553 Active Cleared 18 Sep 2007

• Endoscopic Plication System

  Class II

  FDA 510(k) K023234 Active Cleared 17 Apr 2003