Surgassist Right Angle Linear Cutter 30mm, 45mm & 60mm, Models RALC30, RALC45 & RALC60

• • Terminated Z-0394-2010 FDA Unclassified (pre-2012) ·initiated 23 Sep 2009

  Lack of assurance that products were manufactured under GMPs. This action is being undertaken due to certain products potentially exhibiting compromised staple formation or cutting which in some instances may result in extended surgical time for the patient.

510(k) Number

K021701 ↗

FDA Product Code

GDW

Models / Variants

RALC30

RALC45

RALC60

Device Class

Class II

Regulation

21 CFR Part 878.4750

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

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