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FDA 510(k)

Ion Endoluminal System (IF1000)

K-Number: K252528 · 2025-09-05

ApplicantIntuitive Surgical, Inc.
Decision Date2025-09-05
Product CodeEOQ
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

Ion Endoluminal System (IF1000) is a medical device manufactured by Intuitive Surgical, Inc.. It received FDA 510(k) clearance on 2025-09-05 under approval number K252528. 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 (IF1000)?

Ion Endoluminal System (IF1000) is a medical device that received FDA 510(k) clearance on 2025-09-05. It is manufactured by Intuitive Surgical, Inc.. The 510(k) number is K252528.

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

Ion Endoluminal System (IF1000) received FDA 510(k) clearance on 2025-09-05, under approval number K252528.

What company makes Ion Endoluminal System (IF1000)?

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

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

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

Related Clinical Trials

NCT06004440 Real World Registry for Use of the Ion Endoluminal System ACTIVE_NOT_RECRUITING NCT06133387 PARADIGM - En Bloc Trial With the EndoQuest Endoluminal Surgical (ELS) System RECRUITING NCT06308120 A Trial to Compare Robotic Assisted Bronchoscopy Ion's Clinical Utility for Peripheral Lung Nodule Access and Diagnosis to ENB ACTIVE_NOT_RECRUITING

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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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