Ion Endoluminal System ; Flexision Biopsy Needle
FDA 510(k) clearance K182188 · decided 2019-02-14
Clearance details
- K-number
- K182188
- Device name
- Ion Endoluminal System ; Flexision Biopsy Needle
- Applicant
- Intuitive Surgical
- Decision
- Substantially Equivalent
- Date received
- 2018-08-13
- Decision date
- 2019-02-14
- Days to decision
- 185 days
- Clearance type
- Traditional
- Product code
- EOQ
- Device class
- 2
- Regulation number
- 874.4680
- Medical specialty
- Ear, Nose, Throat
- Advisory committee
- Ear, Nose, Throat
- Location
- Sunnyvale, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Ion Endoluminal System, REF: 380748-65 recall (Z-2720-2024) | Intuitive Surgical, Inc. | 2024-08-23 |