Disposable Ureteral Guide Sheath— 510(k) K241181
Substantially EquivalentDongguan Zsr Biomedical Technology Company Limited
FDA 510(k) clearance K241181 for Disposable Ureteral Guide Sheath, Substantially Equivalent on 2024-08-02. Applicant: Dongguan Zsr Biomedical Technology Company Limited.
Clearance details
- Applicant
- Dongguan Zsr Biomedical Technology Company Limited
- Product code
- Code FED
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Dongguan, 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.