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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Interventional Fluoroscopic X-Ray System
510(k) Number K252500
Device Name CARA System
Applicant
Cara Medical, Ltd.
Craigmuir Chambers
Rd. Town,  VG VG 1110
Applicant Contact Yael Goode
Correspondent
QR Wise, Ltd.
Hamapilim 4
Nesher,  IL 3661079
Correspondent Contact Shimon Vaknin
Regulation Number892.1650
Classification Product Code
OWB  
Subsequent Product Code
LLZ  
Date Received08/08/2025
Decision Date 02/20/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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