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FDA 510(k)

Paradigm System

K-Number: K222291 · 2023-04-21

ApplicantProprio, Inc.
Decision Date2023-04-21
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Paradigm System is the device name listed in this FDA 510(k) record. The listed applicant is Proprio, Inc.. It received FDA 510(k) clearance on 2023-04-21 under 510(k) number K222291. 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 2023-04-21. The listed applicant is Proprio, Inc.. The 510(k) number is K222291.

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

Paradigm System received FDA 510(k) clearance on 2023-04-21, under 510(k) number K222291.

Who is the listed applicant for Paradigm System?

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

What is the FDA product code for Paradigm System?

The FDA product code for Paradigm System is OLO.

Other records listing Proprio, Inc. as applicant

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.

K252950Paradigm SystemK250879Paradigm SystemK243258Paradigm System

Related Devices (Code: OLO)

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.

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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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