Single-use Ureteral Access Sheath— 510(k) K250695
Substantially EquivalentShenzhen HugeMed Medical Technical Development Co., Ltd.
FDA 510(k) clearance K250695 for Single-use Ureteral Access Sheath, Substantially Equivalent on 2025-07-08. Applicant: Shenzhen HugeMed Medical Technical Development Co., Ltd..
Clearance details
- Applicant
- Shenzhen HugeMed Medical Technical Development Co., Ltd.
- Product code
- Code FED
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Shenzhen, CN
Adverse events under product code FED
product code FED- Death
- 10
- Total
- 10
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.