Ligasure 5mm Laparoscopic Sealer-Divider, Model LS1500

• 2 recalls, same reason

  • Terminated Z-0640-2012 FDA Unclassified (pre-2012) ·initiated 4 Nov 2011
  • Terminated Z-0641-2012 FDA Unclassified (pre-2012) ·initiated 4 Nov 2011

  Retaining pins in handle assembly may disengage and fall into surgical field or compromise handle unlatching.

510(k) Number

K031011 ↗

FDA Product Code

GEI

Device Class

Class II

Regulation

21 CFR Part 878.4400

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

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