1788 4K Camera System with Advanced Imaging Modality; L12 LED Light Source with AIM
Summary
Stryker received 510(k) clearance for 1788 4K Camera System with Advanced Imaging Modality; L12 LED Light Source with AIM, a OWN device. Cleared on 2023-09-20.
Details
Source
510(k) Clearance
External ID
K231854
Action Date
2023-09-20
Status
Traditional
Category
device
Product Code
OWN
Product Description
1788 4K Camera System with Advanced Imaging Modality; L12 LED Light Source with AIM. Product code: OWN.
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. Stryker has received 12 total clearances in our database.
Stryker has 12 FDA actions in our database, including 12 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 Stryker have FDA actions?
Stryker has 12 FDA actions in our database, including 0 recalls and 12 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K231854" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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