FDA 510(k)

Paradigm System

K-Number: K243258 · 2025-02-21

Decision Date2025-02-21

Product CodeOLO

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

Paradigm System is a medical device manufactured by Proprio, Inc.. It received FDA 510(k) clearance on 2025-02-21 under approval number K243258. The device is classified under product code OLO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Paradigm System?

Paradigm System is a medical device that received FDA 510(k) clearance on 2025-02-21. It is manufactured by Proprio, Inc.. The 510(k) number is K243258.

When was Paradigm System approved by the FDA?

Paradigm System received FDA 510(k) clearance on 2025-02-21, under approval number K243258.

What company makes Paradigm System?

Paradigm System is manufactured by Proprio, Inc..

What is the FDA product code for Paradigm System?

The FDA product code for Paradigm System is OLO.

Related Clinical Trials

NCT00453505 Modulation of Motor Function by Stimulation of the Central and Peripheral Nervous System COMPLETED NCT06133387 PARADIGM - En Bloc Trial With the EndoQuest Endoluminal Surgical (ELS) System RECRUITING NCT06596369 Transcutaneous Spinal Cord Stimulation for Upper Extremity Function RECRUITING

Other Devices by Proprio, Inc.

K222291Paradigm System K252950Paradigm System K250879Paradigm System

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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.