JOINIX CANNULAR SYSTEM
K-Number: K162070 · 2017-03-16
ApplicantAju Pharm Co., Ltd.
Decision Date2017-03-16
Product CodeHRX
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
JOINIX CANNULAR SYSTEM is a medical device manufactured by Aju Pharm Co., Ltd.. It received FDA 510(k) clearance on 2017-03-16 under approval number K162070. The device is classified under product code HRX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the JOINIX CANNULAR SYSTEM?
JOINIX CANNULAR SYSTEM is a medical device that received FDA 510(k) clearance on 2017-03-16. It is manufactured by Aju Pharm Co., Ltd.. The 510(k) number is K162070.
When was JOINIX CANNULAR SYSTEM approved by the FDA?
JOINIX CANNULAR SYSTEM received FDA 510(k) clearance on 2017-03-16, under approval number K162070.
What company makes JOINIX CANNULAR SYSTEM?
JOINIX CANNULAR SYSTEM is manufactured by Aju Pharm Co., Ltd..
What is the FDA product code for JOINIX CANNULAR SYSTEM?
The FDA product code for JOINIX CANNULAR SYSTEM is HRX.
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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.