K230439
- 510(k) number
- K230439
- Device name
- WellCare Anoscope
- Applicant
- Well Care (Wuhan) Medical Technology Co., Ltd. CN
- Product code
- FER — Anoscope And Accessories
- Decision date
- 2023-12-22
- Date received
- 2023-02-21
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 1.2 MB · U.S. public domain
Also available from FDA: K230439.pdf
Official FDA record: K230439
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.