510(k) K221713
K221713 is an FDA 510(k) premarket notification submitted by Hangzhou AGS MedTech Co., Ltd. for the device "Polypectomy Snare". The FDA issued a decision of Substantially Equivalent on March 3, 2023. The device falls under product code FDI (Snare, Flexible), a Class II device regulated under 21 CFR 876.4300. Hangzhou AGS MedTech Co., Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 3, 2023
- Date Received
- June 13, 2022
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Snare, Flexible
- Device Class
- Class II
- Regulation Number
- 876.4300
- Review Panel
- GU
- Submission Type