FDA 510(k)

Ion Endoluminal System (Ion Fully Articulating Catheter) (IF1000)

K-Number: K240135 · 2024-04-03

Decision Date2024-04-03

Product CodeEOQ

Advisory CommitteeEN

DecisionSubstantially Equivalent

Device Summary

Ion Endoluminal System (Ion Fully Articulating Catheter) (IF1000) is a medical device manufactured by Intuitive Surgical, Inc.. It received FDA 510(k) clearance on 2024-04-03 under approval number K240135. The device is classified under product code EOQ. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Ion Endoluminal System (Ion Fully Articulating Catheter) (IF1000)?

Ion Endoluminal System (Ion Fully Articulating Catheter) (IF1000) is a medical device that received FDA 510(k) clearance on 2024-04-03. It is manufactured by Intuitive Surgical, Inc.. The 510(k) number is K240135.

When was Ion Endoluminal System (Ion Fully Articulating Catheter) (IF1000) approved by the FDA?

Ion Endoluminal System (Ion Fully Articulating Catheter) (IF1000) received FDA 510(k) clearance on 2024-04-03, under approval number K240135.

What company makes Ion Endoluminal System (Ion Fully Articulating Catheter) (IF1000)?

Ion Endoluminal System (Ion Fully Articulating Catheter) (IF1000) is manufactured by Intuitive Surgical, Inc..

What is the FDA product code for Ion Endoluminal System (Ion Fully Articulating Catheter) (IF1000)?

The FDA product code for Ion Endoluminal System (Ion Fully Articulating Catheter) (IF1000) is EOQ.

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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.