SurgicalPreview
FDA 510(k) clearance K171534 · decided 2017-11-08
Clearance details
- K-number
- K171534
- Device name
- SurgicalPreview
- Applicant
- Endo Vantage, LLC
- Decision
- Substantially Equivalent
- Date received
- 2017-05-25
- Decision date
- 2017-11-08
- Days to decision
- 167 days
- Clearance type
- Traditional
- Product code
- PZO
- Device class
- 2
- Regulation number
- 892.2050
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Scottsdale, AZ, US
- Third-party review
- No
- Expedited review
- No
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| Sim&Size (K202322) | Sim&Cure | 2020-12-31 |
| Sim&Size (K190049) | Sim&Cure | 2019-09-17 |
Recalls involving this device
No recalls on record reference this clearance.