A-Link Z
K-Number: K201671 · 2021-05-04
ApplicantAcuity Surgical Devices, LLC
Decision Date2021-05-04
Product CodeOVD
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
A-Link Z is a medical device manufactured by Acuity Surgical Devices, LLC. It received FDA 510(k) clearance on 2021-05-04 under approval number K201671. The device is classified under product code OVD. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the A-Link Z?
A-Link Z is a medical device that received FDA 510(k) clearance on 2021-05-04. It is manufactured by Acuity Surgical Devices, LLC. The 510(k) number is K201671.
When was A-Link Z approved by the FDA?
A-Link Z received FDA 510(k) clearance on 2021-05-04, under approval number K201671.
What company makes A-Link Z?
A-Link Z is manufactured by Acuity Surgical Devices, LLC.
What is the FDA product code for A-Link Z?
The FDA product code for A-Link Z is OVD.
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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.