Capsular Shrinkage Electrode

• • Terminated Z-0085-2017 FDA Class II ·initiated 29 Aug 2016

  CONMED received complaints of damage to the CS-023 electrodes shaft insulation which could result in burn marks on the shaft. If the shaft insulation is damaged in any way, it could increase the risk of patient burn.

510(k) Number

K991830 ↗

FDA Product Code

JOS

Device Class

Class II

Regulation

21 CFR Part 878.4400

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

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