FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇹 Italy
Renova Spine Balloon Catheter
K Number: K231340
·
Decision Oct 30, 2023
Classifications
1
FEI Numbers
114
Registration Numbers
114
Same Product Code
107
Applicant Total
4
Review Days
174
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Basic Information
- Device Name
- Renova Spine Balloon Catheter
- K Number
- K231340
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3027
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Biopsybell S.R.L.
- Date Received
- May 9, 2023
- Decision Date
- October 30, 2023
- Product Code
- NDN
- Advisory Committee
- Orthopedic
- Review Advisory Committee
- OR
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| NDN | Cement, Bone, Vertebroplasty | FDA class 2 | Orthopedic |
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Other Clearances by Biopsybell S.R.L.
| K Number | Device Name | ||
|---|---|---|---|
| K203397 | Marrow-Pack (white)- 11gauge/10cm or 13gauge/10cm, Marrow-Tray (red)- 11gauge/10cm or 13gauge/10cm, Marrow-Set (violet)- 11gauge/10cm or 13gauge/10cm, Marrow-kit (grey)- 11gauge/10cm or 13gauge/10cm, Marrow-Stem (green)- 11gauge/10cm or 13gauge/10cm | Jan 11, 2021 | Substantially Equivalent |
| K180315 | DISKOM | Mar 26, 2018 | Substantially Equivalent |
| K130616 | MANUAL-BONE-MARROW-BIOPSY-NEEDLES, SEMI-AUTOMATIC-BIOPSY-NEEDLES, AUTOMATIC-BIOPSY-NEEDLES | Feb 7, 2014 | Substantially Equivalent |