# K182188 (us_fda)

Foundational FDA 510(k) clearance of the Intuitive Ion Endoluminal System (robotic-assisted bronchoscopy for peripheral lung biopsy; clearance also covered the Flexision biopsy needle).

## Key facts

- Jurisdiction: us_fda
- Filing type: fda_510k
- Status: cleared
- Filing number: K182188
- Filing date: 2018-08-13
- Decision date: 2019-02-14
- Verification posture: verified

## Applicant

- [Intuitive Surgical](/companies/intuitive-surgical.md)

## Covered models (1)

- [Ion Endoluminal System](/models/intuitive-ion.md)

## Sources (1)

- [https://api.fda.gov/device/510k.json?search=k_number:K182188](https://api.fda.gov/device/510k.json?search=k_number:K182188)

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