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FDA 510(k)

Surgeon Controlled Arm

K-Number: K223673 · 2023-08-04

Decision Date2023-08-04
Product CodePNL
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Surgeon Controlled Arm is a medical device manufactured by Levita Magnetics International Corp. It received FDA 510(k) clearance on 2023-08-04 under approval number K223673. The device is classified under product code PNL. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Surgeon Controlled Arm?

Surgeon Controlled Arm is a medical device that received FDA 510(k) clearance on 2023-08-04. It is manufactured by Levita Magnetics International Corp. The 510(k) number is K223673.

When was Surgeon Controlled Arm approved by the FDA?

Surgeon Controlled Arm received FDA 510(k) clearance on 2023-08-04, under approval number K223673.

What company makes Surgeon Controlled Arm?

Surgeon Controlled Arm is manufactured by Levita Magnetics International Corp.

What is the FDA product code for Surgeon Controlled Arm?

The FDA product code for Surgeon Controlled Arm is PNL.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.