1688 4K Camera System with Advanced Imaging Modality
Summary
Stryker received 510(k) clearance for 1688 4K Camera System with Advanced Imaging Modality, a GCJ device. Cleared on 2022-08-19.
Details
Source
510(k) Clearance
External ID
K222130
Action Date
2022-08-19
Status
Special
Category
device
Product Code
GCJ
Product Description
1688 4K Camera System with Advanced Imaging Modality. Product code: GCJ.
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 "K222130" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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