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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Aju Pharm Co., Ltd.. It received FDA 510(k) clearance on 2017-03-16 under 510(k) 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. The listed applicant is Aju Pharm Co., Ltd.. The 510(k) number is K162070.

When did JOINIX CANNULAR SYSTEM receive FDA 510(k) clearance?

JOINIX CANNULAR SYSTEM received FDA 510(k) clearance on 2017-03-16, under 510(k) number K162070.

Who is the listed applicant for JOINIX CANNULAR SYSTEM?

The FDA 510(k) record lists Aju Pharm Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

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.

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