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FDA 510(k)

Ion Endoluminal System (Ion Fully Articulating Catheter), Ion Endoluminal System (Ion Peripheral Vision Probe)

K-Number: K212048 · 2021-08-26

ApplicantIntuitive Surgical, Inc.
Decision Date2021-08-26
Product CodeEOQ
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

Ion Endoluminal System (Ion Fully Articulating Catheter), Ion Endoluminal System (Ion Peripheral Vision Probe) is a medical device manufactured by Intuitive Surgical, Inc.. It received FDA 510(k) clearance on 2021-08-26 under approval number K212048. 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), Ion Endoluminal System (Ion Peripheral Vision Probe)?

Ion Endoluminal System (Ion Fully Articulating Catheter), Ion Endoluminal System (Ion Peripheral Vision Probe) is a medical device that received FDA 510(k) clearance on 2021-08-26. It is manufactured by Intuitive Surgical, Inc.. The 510(k) number is K212048.

When was Ion Endoluminal System (Ion Fully Articulating Catheter), Ion Endoluminal System (Ion Peripheral Vision Probe) approved by the FDA?

Ion Endoluminal System (Ion Fully Articulating Catheter), Ion Endoluminal System (Ion Peripheral Vision Probe) received FDA 510(k) clearance on 2021-08-26, under approval number K212048.

What company makes Ion Endoluminal System (Ion Fully Articulating Catheter), Ion Endoluminal System (Ion Peripheral Vision Probe)?

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

What is the FDA product code for Ion Endoluminal System (Ion Fully Articulating Catheter), Ion Endoluminal System (Ion Peripheral Vision Probe)?

The FDA product code for Ion Endoluminal System (Ion Fully Articulating Catheter), Ion Endoluminal System (Ion Peripheral Vision Probe) is EOQ.

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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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