510(k) K231340
K231340 is an FDA 510(k) premarket notification submitted by Biopsybell S.R.L. for the device "Renova Spine Balloon Catheter". The FDA issued a decision of Substantially Equivalent on October 30, 2023. The device falls under product code NDN (Cement, Bone, Vertebroplasty), a Class II device regulated under 21 CFR 888.3027. Biopsybell S.R.L. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 30, 2023
- Date Received
- May 9, 2023
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Cement, Bone, Vertebroplasty
- Device Class
- Class II
- Regulation Number
- 888.3027
- Review Panel
- OR
- Submission Type