510(k) K223138
K223138 is an FDA 510(k) premarket notification submitted by Creo Medical, Ltd. for the device "AB1 Electrosurgical Instrument, Creo Electrosurgical System". The FDA issued a decision of Substantially Equivalent on June 26, 2023. The device falls under product code NEY (System, Ablation, Microwave And Accessories), a Class II device regulated under 21 CFR 878.4400. Creo Medical, Ltd. has at least 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 26, 2023
- Date Received
- October 4, 2022
- 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