WallFlex Biliary RX Stent System; Epic Biliary Stent System; WallFlex Biliary RX Fully Covered Stent System RMV
Summary
Boston Scientific received 510(k) clearance for WallFlex Biliary RX Stent System; Epic Biliary Stent System; WallFlex Biliary RX Fully Covered Stent System RMV, a FGE device. Cleared on 2024-08-30.
Details
Source
510(k) Clearance
External ID
K240464
Action Date
2024-08-30
Status
Traditional
Category
device
Product Code
FGE
Product Description
WallFlex Biliary RX Stent System; Epic Biliary Stent System; WallFlex Biliary RX Fully Covered Stent System RMV. Product code: FGE.
Company
Context & Analysis
A 510(k) clearance means the FDA determined this device is substantially equivalent to a legally marketed device. This is one of 403 device clearances issued this month. Boston Scientific has received 15 total clearances in our database.
Boston Scientific has 15 FDA actions in our database, including 15 clearances.
Frequently Asked Questions
What does 510(k) clearance mean?
A 510(k) is an FDA premarket submission demonstrating that a device is substantially equivalent to a legally marketed device. It does NOT mean FDA approval — it means the device is cleared for marketing because it's similar enough to an existing cleared device. Most medical devices reach market via 510(k) rather than full PMA approval.
How often does Boston Scientific have FDA actions?
Boston Scientific has 15 FDA actions in our database, including 0 recalls and 15 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K240464" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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