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510(k) K252500

CARA System by Cara Medical, Ltd. — Product Code OWB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 20, 2026
Date Received
August 8, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Interventional Fluoroscopic X-Ray System
Device Class
Class II
Regulation Number
892.1650
Review Panel
RA
Submission Type

Interventional fluoroscopy

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