SpyGlass DS Direct Visualization System
FDA 510(k) clearance K142922 · decided 2015-01-16
Clearance details
- K-number
- K142922
- Device name
- SpyGlass DS Direct Visualization System
- Applicant
- Boston Scientific Corporation
- Decision
- Substantially Equivalent
- Date received
- 2014-10-08
- Decision date
- 2015-01-16
- Days to decision
- 100 days
- Clearance type
- Traditional
- Product code
- FBN
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Marlboro, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.
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