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FDA 510(k)

INTELLIO SHIFT System

K-Number: K232290 · 2023-12-11

ApplicantArthroCare Corporation
Decision Date2023-12-11
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

INTELLIO SHIFT System is a medical device manufactured by ArthroCare Corporation. It received FDA 510(k) clearance on 2023-12-11 under approval number K232290. 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 INTELLIO SHIFT System?

INTELLIO SHIFT System is a medical device that received FDA 510(k) clearance on 2023-12-11. It is manufactured by ArthroCare Corporation. The 510(k) number is K232290.

When was INTELLIO SHIFT System approved by the FDA?

INTELLIO SHIFT System received FDA 510(k) clearance on 2023-12-11, under approval number K232290.

What company makes INTELLIO SHIFT System?

INTELLIO SHIFT System is manufactured by ArthroCare Corporation.

What is the FDA product code for INTELLIO SHIFT System?

The FDA product code for INTELLIO SHIFT System is GEI.

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Related PubMed Literature

PMID: 40415770 Use of cardiovascular registries in regulatory pathways: perspectives from the EU-MDR Cardiovascular Collaboratory. REC, interventional cardiology (2024)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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