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510(k) K261037

780 nm SPY Portable Handheld Imaging (SPY-PHI) System by Stryker Endoscopy — Product Code IZI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 28, 2026
Date Received
March 30, 2026
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Angiographic
Device Class
Class II
Regulation Number
892.1600
Review Panel
RA
Submission Type

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