SpyGlass DS Direct Visualization System— 510(k) K142922
Substantially EquivalentBoston Scientific Corporation
FDA 510(k) clearance K142922 for SpyGlass DS Direct Visualization System, Substantially Equivalent on 2015-01-16. 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
- Traditional
- Location
- Marlboro, MA, US
Recent devices under product code FBN
view all- K254153 — Single-use Video Scope; PB Digital Controller
- K253139 — Disposable Distal Cap
- K251338 — Cholangioscope Visualization System (Single-use Video Cholangioscope: SCV-P-01G, SCV-P-02G +1 more
- 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 →
Recalls naming K142922
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K142922.
Data sourced from openFDA. This site is unofficial and independent of the FDA.