SpyScope DS Access and Delivery Catheter, SpyScope DS II Access and Delivery Catheter, SpyGlass DS Digital Controller— 510(k) K183636
Substantially EquivalentBoston Scientific Corporation
FDA 510(k) clearance K183636 for SpyScope DS Access and Delivery Catheter, SpyScope DS II Access and Delivery Catheter, SpyGlass DS Digital Controller, Substantially Equivalent on 2019-01-22. Applicant: Boston Scientific Corporation. Device class: 2.
Clearance details
- Applicant
- Boston Scientific Corporation
- Product code
- Code FBN
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Marlboro, MA, US
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- K251170 — Tangent Single-Use Digital System: Tangent Single-Use Digital Catheter and Tangent Digital Controller
- K243535 — Flexible Video-Choledochoscope (CHV-110J-U); Flexible Video-Choledochoscope (CHV-US120J-U)
More clearances from Boston Scientific Corporation
view allAdverse events under product code FBN
product code FBN- Death
- 8
- Malfunction
- 951
- Total
- 959
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.