Pure Vu System
FDA 510(k) clearance K181437 · decided 2018-06-21
Clearance details
- K-number
- K181437
- Device name
- Pure Vu System
- Applicant
- Motus GI Medical Technologies , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2018-06-01
- Decision date
- 2018-06-21
- Days to decision
- 20 days
- Clearance type
- Special
- Product code
- FDF
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Tirat Carmel, IL
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.