FDA 510(k)

Cannulated PsiFGuard

K-Number: K241895 · 2024-09-26

Decision Date2024-09-26

Product CodeSCY

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Cannulated PsiFGuard is the device name listed in this FDA 510(k) record. The listed applicant is Spineguard. It received FDA 510(k) clearance on 2024-09-26 under 510(k) 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. The listed applicant is Spineguard. The 510(k) number is K241895.

When did Cannulated PsiFGuard receive FDA 510(k) clearance?

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

Who is the listed applicant for Cannulated PsiFGuard?

The FDA 510(k) record lists Spineguard as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Cannulated PsiFGuard?

The FDA product code for Cannulated PsiFGuard is SCY.

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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.