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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stapler, Surgical
510(k) Number K234039
Device Name AEON Endoscopic Powered Stapler (Short/AEPH060); AEON Endoscopic Powered Stapler (Medium/AEPH160); AEON Endoscopic Powered Stapler (Long/AEPH260)
Applicant
Lexington Medical, Inc.
23 Crosby Dr.
Bedford,  MA  01730
Applicant Contact Sali Gully
Correspondent
Lexington Medical, Inc.
23 Crosby Dr.
Bedford,  MA  01730
Correspondent Contact Sali Gully
Regulation Number878.4740
Classification Product Code
GAG  
Subsequent Product Code
GDW  
Date Received12/21/2023
Decision Date 05/07/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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