510(k) K233200
K233200 is an FDA 510(k) premarket notification submitted by GEMSS HEALTHCARE CO., LTD. for the device "XPLUS 35 Series (XPLUS 35, XPLUS 35FD)". The FDA issued a decision of Substantially Equivalent on November 16, 2023. The device falls under product code OWB (Interventional Fluoroscopic X-Ray System), a Class II device regulated under 21 CFR 892.1650. GEMSS HEALTHCARE CO., LTD. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 16, 2023
- Date Received
- September 28, 2023
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Interventional Fluoroscopic X-Ray System
- Device Class
- Class II
- Regulation Number
- 892.1650
- Review Panel
- RA
- Submission Type
Interventional fluoroscopy