K231633
- 510(k) number
- K231633
- Device name
- Disposable Hemoclip (AF series)
- Applicant
- Alton (Shanghai) Medical Instruments Co., Ltd. CN
- Product code
- PKL — Hemostatic Metal Clip For The Gi Tract
- Decision date
- 2024-01-11
- Date received
- 2023-06-05
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
510(k) Summary (official FDA PDF): K231633.pdf
Official FDA record: K231633
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.