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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
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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