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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 K210266
Device Name OverStitch Sx Endoscopic Suturing System
Applicant
Apollo Endosurgery Inc.
1120 South Capital of Texas Hwy., Suite 300
austin,  TX  78746
Applicant Contact david hooper
Correspondent
Apollo Endosurgery Inc.
1120 South Capital of Texas Hwy., Suite 300
austin,  TX  78746
Correspondent Contact david hooper
Regulation Number876.1500
Classification Product Code
OCW  
Date Received02/01/2021
Decision Date 03/02/2021
Decision substantially equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
summary summary
Type Special
Reviewed by Third Party No
Combination Product No
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