Regulatory filing
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).
fda 510k · cleared · decided 2019-02-14
Machine-readable surfaces
- Markdown mirror: /regulatory-filings/fda-510k-intuitive-ion-2019.md
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- REST API: /v1/filings/d04f8a5a-914a-4df3-affc-c71e062d3afc
- Revision history: /regulatory-filings/fda-510k-intuitive-ion-2019/history
- Data documentation: /data
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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
Covered models (1)
Sources (1)
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Identity
d04f8a5a-914a-4df3-affc-c71e062d3afc