Integrated Drive/Pump System

• • Terminated Z-0041-05 FDA Unclassified (pre-2012) ·initiated 26 Aug 2004

  The pouch containing the sterile product is not completely seal on all products. Therefore , the sterility of the device is questionable.

510(k) Number

K981636 ↗

FDA Product Code

HRX

Device Class

Class II

Regulation

21 CFR Part 888.1100

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

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• Resection Ablator

  Class II

  FDA 510(k) K013369 Active Cleared 4 Apr 2002

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