Disposable Hemoclip (AF series)— 510(k) K231633
Substantially EquivalentAlton (Shanghai) Medical Instruments Co., Ltd.
FDA 510(k) clearance K231633 for Disposable Hemoclip (AF series), Substantially Equivalent on 2024-01-11. Applicant: Alton (Shanghai) Medical Instruments Co., Ltd..
Clearance details
- Applicant
- Alton (Shanghai) Medical Instruments Co., Ltd.
- Product code
- Code PKL
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Shanghai, CN
Adverse events under product code PKL
product code PKL- Death
- 9
- Injury
- 489
- Malfunction
- 4,698
- Other
- 1
- Total
- 5,197
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.