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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoscopic Tissue Approximation Device
510(k) Number K243750
Device Name SimpleStitch Suturing System
Applicant
Envision Endoscopy
204 Second Ave., 2nd Floor
Waltham,  MA  02451
Applicant Contact Azadeh Khanicheh
Correspondent
Envision Endoscopy
204 Second Ave., 2nd Floor
Waltham,  MA  02451
Correspondent Contact Azadeh Khanicheh
Regulation Number876.1500
Classification Product Code
OCW  
Date Received12/05/2024
Decision Date 04/17/2025
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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