Home / 510(k) Clearances / K102325

510(k) K102325

IDRIVE SYSTEM (I DRIVE POWER HANDLE, IDRIVE (RALC) SINGLE USE RELOAD) by Covidien, LLC, Formerly Registered AS Tyco Healthca — Product Code GDW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 13, 2010
Date Received
August 17, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Staple, Implantable
Device Class
Class II
Regulation Number
878.4750
Review Panel
SU
Submission Type

Other clearances by Covidien, LLC, Formerly Registered AS Tyco Healthca

  • K102605 — MAHURKAR TRIPLE LUMEN DIALYSIS CATHETER (December 22, 2010)

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