FDA 510(k)
FDA class 2
Unknown
🇺🇸 United States
WallFlex Biliary RX Stent System; Epic Biliary Stent System; WallFlex Biliary RX Fully Covered Stent System RMV
K Number: K240464
·
Decision Aug 30, 2024
Classifications
1
FEI Numbers
143
Registration Numbers
143
Same Product Code
473
Applicant Total
58
Review Days
196
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Basic Information
- Device Name
- WallFlex Biliary RX Stent System; Epic Biliary Stent System; WallFlex Biliary RX Fully Covered Stent System RMV
- K Number
- K240464
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5010
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Unknown
- Statement or Summary
- Summary
- Applicant
- Boston Scientific
- Date Received
- February 16, 2024
- Decision Date
- August 30, 2024
- Product Code
- FGE
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| FGE | Stents, Drains And Dilators For The Biliary Ducts | FDA class 2 | Gastroenterology, Urology |
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Other Clearances by Boston Scientific
| K Number | Device Name | ||
|---|---|---|---|
| K260816 | OptiCross Coronary Imaging Catheter (H749518110); OptiCross 6 Coronary Imaging Catheter (H7495181160); OptiCross HD Coronary Imaging Catheter (H74939352040); OptiCross 6 HD Coronary Imaging Catheter (H74939354080); OptiCross Coronary Imaging Catheter (Bagless) (H749518130); OptiCross 6 Coronary Imaging Catheter (Bagless) (H7495181360); OptiCross HD Coronary Imaging Catheter (Bagless) (H74939352050); OptiCross 6 HD Coronary Imaging Catheter (Bagless) (H74939354090) | Apr 8, 2026 | Substantially Equivalent |
| K252910 | Orca Air/Water and Suction Valves | Oct 9, 2025 | Unknown |
| K251291 | Advanix Pancreatic Stent and NaviFlex Rapid Exchange (RX) Pancreatic Delivery System and Pushers | Jul 3, 2025 | Substantially Equivalent |
| K250468 | iSLEEVE Introducer Set | Mar 20, 2025 | Substantially Equivalent |
| K242950 | WallFlex Biliary PLUS RX Stent System | Dec 6, 2024 | Unknown |
| K242507 | OBSIDIO Conformable Embolic | Oct 3, 2024 | Substantially Equivalent |
| K233939 | Ultraflex Esophageal NG Stent System; WallFlex Esophageal Stent System | Apr 29, 2024 | Substantially Equivalent |
| K234002 | ICEfx Cryoablation System (FPRCH8000-02) | Mar 13, 2024 | Substantially Equivalent |
| K232633 | Gold Probe Bipolar Electrohemostasis Catheter; Injection Gold Probe Bipolar Electrohemostasis Catheter | Nov 28, 2023 | Substantially Equivalent |
| K232635 | IceSeed 1.5 CX 90º Needle (H7493967433170); IceSeed 1.5 CX S 90º Needle (H7493967233100) | Nov 22, 2023 | Substantially Equivalent |