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FDA 510(k)

Cannulated PsiFGuard

K-Number: K241895 · 2024-09-26

ApplicantSpineguard
Decision Date2024-09-26
Product CodeSCY
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Cannulated PsiFGuard is a medical device manufactured by Spineguard. It received FDA 510(k) clearance on 2024-09-26 under approval number K241895. The device is classified under product code SCY. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Cannulated PsiFGuard?

Cannulated PsiFGuard is a medical device that received FDA 510(k) clearance on 2024-09-26. It is manufactured by Spineguard. The 510(k) number is K241895.

When was Cannulated PsiFGuard approved by the FDA?

Cannulated PsiFGuard received FDA 510(k) clearance on 2024-09-26, under approval number K241895.

What company makes Cannulated PsiFGuard?

Cannulated PsiFGuard is manufactured by Spineguard.

What is the FDA product code for Cannulated PsiFGuard?

The FDA product code for Cannulated PsiFGuard is SCY.

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.