Express SD Biliary Monorail Premounted Stent System— 510(k) K152607
Substantially EquivalentBoston Scientific
FDA 510(k) clearance K152607 for Express SD Biliary Monorail Premounted Stent System, Substantially Equivalent on 2015-10-27. Applicant: Boston Scientific. Device class: 2.
Clearance details
- Applicant
- Boston Scientific
- Product code
- Code FGE
- Device class
- Class 2
- Regulation
- 21 CFR 876.5010
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Maple Grove, MN, US
Recent devices under product code FGE
view all- K260835 — ARCHIMEDES Biodegradable Stent (Medium)
- K253393 — Single-use Balloon Dilatation Catheter (AG-5251-083018 AG-5251-085518 AG-5251-088018 AG-5251-083019 AG-5251-085519 AG-5251-088019 AG-5251-083021 AG-5251-085521 AG-5251-088021 AG-5251-083024 AG-5251-085524 AG-5251-088024 AG-5251-103018 AG-5251-105518 AG-5251-108018 AG-5251-103019 AG-5251-105519 AG-5251-108019 AG-5251-103021 AG-5251-105521 AG-5251-108021 AG-5251-103024 AG-5251-105524 AG-5251-108024 AG-5251-123018 AG-5251-125518 AG-5251-128018 AG-5251-123019 AG-5251-125519 AG-5251-128019
- K253832 — Dilation Balloon Catheter
- K251658 — Endoflux Biliary & Pancreatic Stent Sets
- K253987 — BARE Wireguided Balloon Dilation Catheter (1235)
More clearances from Boston Scientific
view all- K253692 — AVVIGO+ Multi-Modality Guidance System
- K262406 — EluPro Antibiotic-Eluting BioEnvelope
- K260816 — OptiCross Coronary Imaging Catheter (H749518110) +7 more
- K252910 — Orca Air/Water and Suction Valves
- K251291 — Advanix Pancreatic Stent and NaviFlex Rapid Exchange (RX) Pancreatic Delivery System and Pushers
Adverse events under product code FGE
product code FGE- Death
- 52
- Injury
- 2,347
- Malfunction
- 9,798
- Other
- 1
- Total
- 12,198
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.