510(k) K143129
K143129 is an FDA 510(k) premarket notification submitted by Ezisurg Medical Co., Ltd. for the device "easyEndo Linear Cutting Stapler and Loading Unit for Single Use(Stapler;Loading Unit)". The FDA issued a decision of Substantially Equivalent on Jan 29, 2015. The device falls under product code GDW (Staple, Implantable), a Class II device regulated under 21 CFR 878.4750. Ezisurg Medical Co., Ltd. has 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jan 29, 2015
- Date Received
- Oct 31, 2014
- 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
- 510(k)