Xpert Wrist
K-Number: K213214 · 2021-11-24
ApplicantNewclip Technics
Decision Date2021-11-24
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
Xpert Wrist is a medical device manufactured by Newclip Technics. It received FDA 510(k) clearance on 2021-11-24 under approval number K213214. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Xpert Wrist?
Xpert Wrist is a medical device that received FDA 510(k) clearance on 2021-11-24. It is manufactured by Newclip Technics. The 510(k) number is K213214.
When was Xpert Wrist approved by the FDA?
Xpert Wrist received FDA 510(k) clearance on 2021-11-24, under approval number K213214.
What company makes Xpert Wrist?
Xpert Wrist is manufactured by Newclip Technics.
What is the FDA product code for Xpert Wrist?
The FDA product code for Xpert Wrist is HRS.
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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.