STA Satellite Max®
Summary
Diagnostica Stago, Inc. received 510(k) clearance for STA Satellite Max®, a JPA device. Cleared on 2026-04-27.
Details
Source
510(k) Clearance
External ID
K253658
Action Date
2026-04-27
Status
Traditional
Category
device
Product Code
JPA
Product Description
STA Satellite Max®. Product code: JPA.
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.
Diagnostica Stago, Inc. has 13 FDA actions in our database, including 12 recalls and 1 clearance.
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 Diagnostica Stago, Inc. have FDA actions?
Diagnostica Stago, Inc. has 13 FDA actions in our database, including 12 recalls and 1 device clearance.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K253658" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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