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510(k) K232842

Balloon Inflation System by Ningbo Hicren Biotechnology Co., Ltd. — Product Code NDN

K232842 is an FDA 510(k) premarket notification submitted by Ningbo Hicren Biotechnology Co., Ltd. for the device "Balloon Inflation System". The FDA issued a decision of Substantially Equivalent on February 29, 2024. The device falls under product code NDN (Cement, Bone, Vertebroplasty), a Class II device regulated under 21 CFR 888.3027.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 29, 2024
Date Received
September 14, 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

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FDA data resources