510(k) K202709

Disposable Powered Endoscopic Linear Cutting Staplers and Cartridges by Ningbo Verykind Medical Device Co., Ltd. — Product Code GDW

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