780 nm SPY Portable Handheld Imaging (SPY-PHI) System
Summary
Stryker Endoscopy received 510(k) clearance for 780 nm SPY Portable Handheld Imaging (SPY-PHI) System, a IZI device. Cleared on 2026-05-28.
Details
Source
510(k) Clearance
External ID
K261037
Action Date
2026-05-28
Status
Traditional
Category
device
Product Code
IZI
Product Description
780 nm SPY Portable Handheld Imaging (SPY-PHI) System. Product code: IZI.
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 413 device clearances issued this month. Stryker Endoscopy has received 19 total clearances in our database.
Stryker Endoscopy has 19 FDA actions in our database, including 19 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 Endoscopy have FDA actions?
Stryker Endoscopy has 19 FDA actions in our database, including 0 recalls and 19 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K261037" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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