Polypectomy Snare
FDA 510(k) clearance K221713 · decided 2023-03-03
Clearance details
- K-number
- K221713
- Device name
- Polypectomy Snare
- Applicant
- Hangzhou AGS MedTech Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2022-06-13
- Decision date
- 2023-03-03
- Days to decision
- 263 days
- Clearance type
- Traditional
- Product code
- FDI
- Device class
- 2
- Regulation number
- 876.4300
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Hangzhou, CN
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.