StoneSmart Connect Console, LithoVue Elite Standard Deflection, LithoVue Elite Reverse Deflection
Summary
Boston Scientific Corporation - received 510(k) clearance for StoneSmart Connect Console, LithoVue Elite Standard Deflection, LithoVue Elite Reverse Deflection, a FGB device. Cleared on 2023-12-12.
Details
Source
510(k) Clearance
External ID
K233645
Action Date
2023-12-12
Status
Special
Category
device
Product Code
FGB
Product Description
StoneSmart Connect Console, LithoVue Elite Standard Deflection, LithoVue Elite Reverse Deflection. Product code: FGB.
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 "K233645" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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