K240978
- 510(k) number
- K240978
- Device name
- SeleneView® Single-Use Digital Hysteroscope (HC29, HC29-G, HC35, HC35-G, HO35, HO35-G, HO42, HO42-G)
- Applicant
- MacroLux Medical Technology Co., Ltd. CN
- Product code
- HIH — Hysteroscope (And Accessories)
- Decision date
- 2024-08-16
- Date received
- 2024-04-10
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Obstetrics/Gynecology
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K240978.pdf
Official FDA record: K240978
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.