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FDA 510(k)

Surgify Halo

K-Number: K232684 · 2023-11-29

ApplicantSurgify Medical OY
Decision Date2023-11-29
Product CodeHBE
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Surgify Halo is a medical device manufactured by Surgify Medical OY. It received FDA 510(k) clearance on 2023-11-29 under approval number K232684. The device is classified under product code HBE. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Surgify Halo?

Surgify Halo is a medical device that received FDA 510(k) clearance on 2023-11-29. It is manufactured by Surgify Medical OY. The 510(k) number is K232684.

When was Surgify Halo approved by the FDA?

Surgify Halo received FDA 510(k) clearance on 2023-11-29, under approval number K232684.

What company makes Surgify Halo?

Surgify Halo is manufactured by Surgify Medical OY.

What is the FDA product code for Surgify Halo?

The FDA product code for Surgify Halo is HBE.

Other Devices by Surgify Medical OY

K251433Surgify Halo (54.085.SHD.H1); Surgify Halo (54.140.SHD.H1); Surgify Halo (54.070.NVG.H1); Surgify Halo (54.125.NVG.H1); Surgify Halo (54.000.SEE.H1); Surgify Halo (40.070.NVG.H1); Surgify Halo (40.125.NVG.H1); Surgify Halo (40.000.SEE.H1) K250380Surgify Halo (54.085.SHD.H1); Surgify Halo (54.140.SHD.H1); Surgify Halo (54.070.NVG.H1); Surgify Halo (54.125.NVG.H1); Surgify Halo (54.000.SEE.H1) K253627Surgify Halo (54.085.SHD.U1); Surgify Halo (54.140.SHD. U1); Surgify Halo (54.070.NVG.U1); Surgify Halo (54.125.NVG.U1); Surgify Halo (54.000.SEE.U1); Surgify Halo (40.070.NVG.U1); Surgify Halo (40.125.NVG.U1); Surgify Halo (40.000.SEE.U1); Surgify Halo (30.070.NVG.U2); Surgify Halo (30.125.NVG.U2); Surgify Halo (30.000.SEE.U2)

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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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