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510(k) K214004

CCBIO ASCPO Needle by Cc Biotechnology Corporation — Product Code FMI

K214004 is an FDA 510(k) premarket notification submitted by Cc Biotechnology Corporation for the device "CCBIO ASCPO Needle". The FDA issued a decision of Substantially Equivalent on Dec 13, 2022. The device falls under product code FMI (Needle, Hypodermic, Single Lumen), a Class II device regulated under 21 CFR 880.5570.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Dec 13, 2022
Date Received
Dec 21, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Needle, Hypodermic, Single Lumen
Device Class
Class II
Regulation Number
880.5570
Review Panel
HO
Submission Type
510(k)

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FDA data resources