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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 the device name listed in this FDA 510(k) record. The listed applicant is Prana Surgical. It received FDA 510(k) clearance on 2026-04-01 under 510(k) 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. The listed applicant is Prana Surgical. The 510(k) number is K253405.

When did Prana System receive FDA 510(k) clearance?

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

Who is the listed applicant for Prana System?

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

What is the FDA product code for Prana System?

The FDA product code for Prana System is GEI.

Related Devices (Code: GEI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261179AlphaTriPart - Monopolar MIC InstrumentsGimmi GmbHK253504Volnewmer™Classys, Inc.K254056THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type S (TB-0545FCS); THUNDERBEAT 5 mm, 35 cm, Front-actuated Grip Type S (TB-0535FCS); THUNDERBEAT 5 mm, 20 cm, Front-actuated Grip Type S (TB-0520FCS)Olympus Medical Systems Corp.K253484LUTRONIC GENIUSCynosure Lutronic Technology CorporationK251492Irrigation Tubing Bipolar Cord SetNew Deantronics Taiwan , Ltd.K260636Remanufactured LigaSure XP Maryland Jaw Sealer/Divider Without Nano-coatingStryker Sustainability Solutions

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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