CCBIO ASCPO Needle
K-Number: K214004 · 2022-12-13
ApplicantCc Biotechnology Corporation
Decision Date2022-12-13
Product CodeFMI
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
CCBIO ASCPO Needle is a medical device manufactured by Cc Biotechnology Corporation. It received FDA 510(k) clearance on 2022-12-13 under approval 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. It is manufactured by Cc Biotechnology Corporation. The 510(k) number is K214004.
When was CCBIO ASCPO Needle approved by the FDA?
CCBIO ASCPO Needle received FDA 510(k) clearance on 2022-12-13, under approval number K214004.
What company makes CCBIO ASCPO Needle?
CCBIO ASCPO Needle is manufactured by Cc Biotechnology Corporation.
What is the FDA product code for CCBIO ASCPO Needle?
The FDA product code for CCBIO ASCPO Needle is FMI.
Related Devices (Code: FMI)
K162516BD Pen NeedleBecton, Dickinson and Company
K160532Greiner HoldexGreiner Bio-One Na, Inc.
K160199Advocate Insulin Pen NeedlesDiabetic Supply of Suncoast, Inc.
K151090CPL Insulin Pen NeedleCpl Co., Ltd.
K160575CareSens Pen Needle, Softip Pen NeedleYidobio, Inc.
K153706Insulin Pen NeedleSteriLance Medical (Suzhou), Inc.
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.