K241181
- 510(k) number
- K241181
- Device name
- Disposable Ureteral Guide Sheath
- Applicant
- Dongguan Zsr Biomedical Technology Company Limited CN
- Product code
- FED — Endoscopic Access Overtube, Gastroenterology-Urology
- Decision date
- 2024-08-02
- Date received
- 2024-04-29
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
510(k) Summary (official FDA PDF): K241181.pdf
Official FDA record: K241181
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.