SmartSurgN Visualization System
FDA 510(k) clearance K213943 · decided 2022-11-29
Clearance details
- K-number
- K213943
- Device name
- SmartSurgN Visualization System
- Applicant
- Smartsurgn Incorporated
- Decision
- Substantially Equivalent
- Date received
- 2021-12-17
- Decision date
- 2022-11-29
- Days to decision
- 347 days
- Clearance type
- Traditional
- Product code
- OWN
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- San Jose, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.