510(k) K252270— Hemoclip
Substantially EquivalentHangzhou AGS MedTech Co., Ltd.
Summary
Hemoclip is an endoscopic hemostasis device — product code PKL covers endoscopic clips used to treat upper and lower GI bleeding, close post-polypectomy defects, and perform other endoscopic hemostatic interventions. Boston Scientific, Olympus, and Cook Medical dominate the US market; Hangzhou AGS is a growing Chinese entrant.
Gastroenterology, Urology panel, Traditional 510(k). PKL clearances turn on predicate comparisons for deployment force, grip pressure, and materials compatibility — well-established parameters in the endoscopic-clip category.
Hangzhou AGS MedTech Co. files from Hangzhou, China. Nine-month review clock, typical for new-entrant Chinese filers on established GI-endoscopy categories.
Clearance details
- Applicant
- Hangzhou AGS MedTech Co., Ltd.
- Product code
- Code PKL
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Hangzhou, 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.