Enseal Ptc Trio

• • Terminated Z-2635-2010 FDA Unclassified (pre-2012) ·initiated 9 Jul 2010 ·on shared 510(k) K070165

  The weld that connects the electrode to the active rod was separated. This connection is critical to the proper function of these devices. If the weld is separated, the product will not deliver energy to the jaws, resulting in the potential for a cut/transection without a seal. Ethicon Endo-Surgery identified this issue during a routine finished goods quality inspection.

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

510(k) Number

K070165 ↗

FDA Product Code

GEI

Device Class

Class II

Regulation

21 CFR Part 878.4400

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Enseal Ptc Tissue Sealing Device

  Class II

  FDA 510(k) K070896 Active Cleared 24 Apr 2007

• Enseal Powertip, Nseal-514D, -525D, -535D, -545D, -514RD, -525RD, -535RD, -545RD, Etrio-314D, -325D, -335D, -345D, Enseal Universal

  Class II

  FDA 510(k) K081129 Active Cleared 28 Jul 2008

• Enseal Tissue Sealing Device

  Class II

  FDA 510(k) K072493 Active Cleared 27 Sep 2007

• Enseal Vessel Sealing & Hemostasis System

  Class II

  FDA 510(k) K050671 Active Cleared 1 Apr 2005

• Surgrx Enseal Vessel Sealing and Hemostasis System Including the Enseal Controller Adapter, Enseal Open and Laparoscopis

  Class II

  FDA 510(k) K031133 Active Cleared 3 Jul 2003

• Surgrx Enseal Vessel Sealing & Hemostasis System

  Class II

  FDA 510(k) K043008 Active Cleared 17 Nov 2004

See all devices from Surgrx, Inc. →