510(k) K152557
K152557 is an FDA 510(k) premarket notification submitted by G21, S.R.L. for the device "Winch Kyphoplasty(15 and 20 mm) 11 Gauge Balloon Catheters". The FDA issued a decision of Substantially Equivalent on February 23, 2016. The device falls under product code NDN (Cement, Bone, Vertebroplasty), a Class II device regulated under 21 CFR 888.3027. G21, S.R.L. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 23, 2016
- Date Received
- September 8, 2015
- 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