510(k) K051276

HYSAFE MICRO MODULAR FORCEPS AND SCISSORS SYSTEM by Richard Wolf Medical Instruments Corp. — Product Code OCZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 28, 2005
Date Received
May 17, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Endoscopic Grasping/Cutting Instrument, Non-Powered
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type

To manually grasp stones, tissues or other objects through an endoscope. To manipulate, sample or cut tissues through an endoscope.