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FDA 510(k)

Prana System

K-Number: K253405 · 2026-04-01

ApplicantPrana Surgical
Decision Date2026-04-01
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Prana System is a medical device manufactured by Prana Surgical. It received FDA 510(k) clearance on 2026-04-01 under approval number K253405. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Prana System?

Prana System is a medical device that received FDA 510(k) clearance on 2026-04-01. It is manufactured by Prana Surgical. The 510(k) number is K253405.

When was Prana System approved by the FDA?

Prana System received FDA 510(k) clearance on 2026-04-01, under approval number K253405.

What company makes Prana System?

Prana System is manufactured by Prana Surgical.

What is the FDA product code for Prana System?

The FDA product code for Prana System is GEI.

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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.

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