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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bronchoscope (Flexible Or Rigid)
510(k) Number K260565
Device Name SmartClip Delivery Catheter (ADR-1715)
Applicant
Elucent Medical
6509 Flying Cloud Dr.
Suite 160
Eden Prairie,  MN  55344
Applicant Contact Jake Burke
Correspondent
Elucent Medical
6509 Flying Cloud Dr.
Suite 160
Eden Prairie,  MN  55344
Correspondent Contact Jake Burke
Regulation Number874.4680
Classification Product Code
EOQ  
Date Received02/19/2026
Decision Date 05/14/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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