Decision Date2022-12-13
Product CodeFMI
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
CCBIO ASCPO Needle is the device name listed in this FDA 510(k) record. The listed applicant is Cc Biotechnology Corporation. It received FDA 510(k) clearance on 2022-12-13 under 510(k) number K214004. The device is classified under product code FMI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the CCBIO ASCPO Needle?
CCBIO ASCPO Needle is a medical device that received FDA 510(k) clearance on 2022-12-13. The listed applicant is Cc Biotechnology Corporation. The 510(k) number is K214004.
When did CCBIO ASCPO Needle receive FDA 510(k) clearance?
CCBIO ASCPO Needle received FDA 510(k) clearance on 2022-12-13, under 510(k) number K214004.
Who is the listed applicant for CCBIO ASCPO Needle?
The FDA 510(k) record lists Cc Biotechnology Corporation as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for CCBIO ASCPO Needle?
The FDA product code for CCBIO ASCPO Needle is FMI.
Related Devices (Code: FMI)
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.