510(k) K233140
K233140 is an FDA 510(k) premarket notification submitted by Hygea Medical Technology Co., Ltd. for the device "Microwave Ablation Device (Exceed S10U); Sterile Microwave Ablation Probe (Exact)". The FDA issued a decision of Substantially Equivalent on January 31, 2024. The device falls under product code NEY (System, Ablation, Microwave And Accessories), a Class II device regulated under 21 CFR 878.4400. Hygea Medical Technology Co., Ltd. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 31, 2024
- Date Received
- September 27, 2023
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Ablation, Microwave And Accessories
- Device Class
- Class II
- Regulation Number
- 878.4400
- Review Panel
- SU
- Submission Type