510(k) K102325
K102325 is an FDA 510(k) premarket notification submitted by Covidien, LLC, Formerly Registered AS Tyco Healthca for the device "IDRIVE SYSTEM (I DRIVE POWER HANDLE, IDRIVE (RALC) SINGLE USE RELOAD)". The FDA issued a decision of Substantially Equivalent on October 13, 2010. The device falls under product code GDW (Staple, Implantable), a Class II device regulated under 21 CFR 878.4750. Covidien, LLC, Formerly Registered AS Tyco Healthca has at least 1 other 510(k) clearance on record.
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