510(k) K202709
K202709 is an FDA 510(k) premarket notification submitted by Ningbo Verykind Medical Device Co., Ltd. for the device "Disposable Powered Endoscopic Linear Cutting Staplers and Cartridges". The FDA issued a decision of Substantially Equivalent on May 18, 2021. The device falls under product code GDW (Staple, Implantable), a Class II device regulated under 21 CFR 878.4750. Ningbo Verykind Medical Device Co., Ltd. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 18, 2021
- Date Received
- September 16, 2020
- 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