Ligasure Laparoscopic Sealer Divider Model LS1100

• 2 recalls, same reason

  • Terminated Z-0772-06 FDA Unclassified (pre-2012) ·initiated 27 Jan 2006
  • Terminated Z-0773-06 FDA Unclassified (pre-2012) ·initiated 27 Jan 2006

  Sealing cycle may be interrupted during vessel ligation procedure, resulting in an incomplete seal.

510(k) Number

K010013 ↗

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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