510(k) K211811
K211811 is an FDA 510(k) premarket notification submitted by Wuxi Beien Surgery Device Co., Ltd. for the device "Disposable Endoscopic Staplers and Reload Unit, Disposable Hemorrhoidal Cutter Staplers, Disposable Linear Cutter Staplers, Disposable Circular Staplers". The FDA issued a decision of Substantially Equivalent on March 3, 2022. The device falls under product code GDW (Staple, Implantable), a Class II device regulated under 21 CFR 878.4750.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 3, 2022
- Date Received
- June 11, 2021
- 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