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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Hemostatic Metal Clip For The Gi Tract
510(k) Number K253734
Device Name Taurus Clip
Applicant
Taurus Endoscopy
1 Pl. De L'Hôpital
Bat. Ihu
Strasbourg,  FR 67000
Applicant Contact Mariel Bolhouse
Correspondent
Taurus Endoscopy
1 Pl. De L'Hôpital
Bat. Ihu
Strasbourg,  FR 67000
Correspondent Contact Mariel Bolhouse
Regulation Number876.4400
Classification Product Code
PKL  
Date Received11/24/2025
Decision Date 03/12/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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