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FDA 510(k)

Ion Endoluminal System ; Flexision Biopsy Needle

K-Number: K182188 · 2019-02-14

ApplicantIntuitive Surgical
Decision Date2019-02-14
Product CodeEOQ
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

Ion Endoluminal System ; Flexision Biopsy Needle is a medical device manufactured by Intuitive Surgical. It received FDA 510(k) clearance on 2019-02-14 under approval number K182188. 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 ; Flexision Biopsy Needle?

Ion Endoluminal System ; Flexision Biopsy Needle is a medical device that received FDA 510(k) clearance on 2019-02-14. It is manufactured by Intuitive Surgical. The 510(k) number is K182188.

When was Ion Endoluminal System ; Flexision Biopsy Needle approved by the FDA?

Ion Endoluminal System ; Flexision Biopsy Needle received FDA 510(k) clearance on 2019-02-14, under approval number K182188.

What company makes Ion Endoluminal System ; Flexision Biopsy Needle?

Ion Endoluminal System ; Flexision Biopsy Needle is manufactured by Intuitive Surgical.

What is the FDA product code for Ion Endoluminal System ; Flexision Biopsy Needle?

The FDA product code for Ion Endoluminal System ; Flexision Biopsy Needle 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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