NaviCam Xpress Stomach System
FDA 510(k) clearance K203192 · decided 2021-05-04
Clearance details
- K-number
- K203192
- Device name
- NaviCam Xpress Stomach System
- Applicant
- Anx Robotica Corp
- Decision
- Substantially Equivalent
- Date received
- 2020-10-28
- Decision date
- 2021-05-04
- Days to decision
- 188 days
- Clearance type
- Traditional
- Product code
- QKZ
- Device class
- 2
- Regulation number
- 876.1310
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Pleasanton, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.