Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra System
Summary
Boston Scientific Corporation received 510(k) clearance for Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra System, a OTN device. Cleared on 2021-07-21.
Details
Source
510(k) Clearance
External ID
K211223
Action Date
2021-07-21
Status
Traditional
Category
device
Product Code
OTN
Product Description
Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra System. Product code: OTN.
Context & Analysis
A 510(k) clearance means the FDA determined this device is substantially equivalent to a legally marketed device. This is one of 413 device clearances issued this month. Boston Scientific Corporation has received 65 total clearances in our database.
Boston Scientific Corporation has 399 FDA actions in our database, including 334 recalls and 65 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 Corporation have FDA actions?
Boston Scientific Corporation has 399 FDA actions in our database, including 334 recalls and 65 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K211223" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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