United States FDA 510(k) clearance K240978Substantially EquivalentSeleneView® Single-Use Digital Hysteroscope (HC29, HC29-G, HC35, HC35-G, HO35, HO35-G, HO42, HO42-G)
- K-Number
- K240978
- Device Class
- Class 2
- Clearance Type
- Traditional
- Contact
- Linbin Ye
- Location
- 301, Bldg. 3, Namtai Inno Park In Guang Ming Ave.GuangmingShenzhenCN
- Medical Specialty
- Obstetrics/Gynecology
- Advisory Committee
- OB
- Date Received
- Apr 10, 2024
- Decision Date
- Aug 16, 2024
- Decision
- Substantially Equivalent
Summary
Access comprehensive regulatory information for SeleneView® Single-Use Digital Hysteroscope (HC29, HC29-G, HC35, HC35-G, HO35, HO35-G, HO42, HO42-G) in the USA medical device market through Pure Global AI's free database. This Class 2 medical device was cleared under FDA 510(k) number K240978 and submitted by MacroLux Medical Technology Co., Ltd.. The clearance decision was Substantially Equivalent on Aug 16, 2024.
This page provides complete clearance details including product code HIH, medical specialty classification (Obstetrics/Gynecology), and regulatory compliance information from the official FDA OpenFDA database. Pure Global AI offers free access to FDA 510(k) clearances from 1976 to present, helping global MedTech companies navigate USA FDA regulations efficiently.