Apex Locator (AL-Pex), Apex Locator (AL-Pex+)
K-Number: K232717 · 2023-12-22
ApplicantChangzhou Haili Medical Co., Ltd.
Decision Date2023-12-22
Product CodeLQY
DecisionSubstantially Equivalent
Device Summary
Apex Locator (AL-Pex), Apex Locator (AL-Pex+) is a medical device manufactured by Changzhou Haili Medical Co., Ltd.. It received FDA 510(k) clearance on 2023-12-22 under approval number K232717. The device is classified under product code LQY. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Apex Locator (AL-Pex), Apex Locator (AL-Pex+)?
Apex Locator (AL-Pex), Apex Locator (AL-Pex+) is a medical device that received FDA 510(k) clearance on 2023-12-22. It is manufactured by Changzhou Haili Medical Co., Ltd.. The 510(k) number is K232717.
When was Apex Locator (AL-Pex), Apex Locator (AL-Pex+) approved by the FDA?
Apex Locator (AL-Pex), Apex Locator (AL-Pex+) received FDA 510(k) clearance on 2023-12-22, under approval number K232717.
What company makes Apex Locator (AL-Pex), Apex Locator (AL-Pex+)?
Apex Locator (AL-Pex), Apex Locator (AL-Pex+) is manufactured by Changzhou Haili Medical Co., Ltd..
What is the FDA product code for Apex Locator (AL-Pex), Apex Locator (AL-Pex+)?
The FDA product code for Apex Locator (AL-Pex), Apex Locator (AL-Pex+) is LQY.
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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.