Biliary Pancreaticobiliary Scope System— 510(k) K241444
Substantially EquivalentShenzhen HugeMed Medical Technical Development Co., Ltd.
FDA 510(k) clearance K241444 for Biliary Pancreaticobiliary Scope System, Substantially Equivalent on 2025-01-21. Applicant: Shenzhen HugeMed Medical Technical Development Co., Ltd..
Clearance details
- Applicant
- Shenzhen HugeMed Medical Technical Development Co., Ltd.
- Product code
- Code FBN
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Shenzhen, CN
Adverse events under product code FBN
product code FBN- Death
- 8
- Malfunction
- 951
- Total
- 959
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.