K241532
- 510(k) number
- K241532
- Device name
- Flexible Video-Choledo-Cysto-Ureteroscope System (PL-2100)
- Applicant
- Shanghai SeeGen Photoelectric Technology Co., Ltd. CN
- Product code
- FET — Endoscopic Video Imaging System/Component, Gastroent
- Decision date
- 2024-10-22
- Date received
- 2024-05-30
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 1.4 MB · U.S. public domain
Also available from FDA: K241532.pdf
Official FDA record: K241532
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.