FDA 510(k) K171886, OverStitch SX Endoscopic Suturing System (ESS), by Apollo Endosurgery, Inc.
FDA 510(k) K171886, OverStitch SX Endoscopic Suturing System (ESS), by Apollo Endosurgery, Inc.
Device Classification Name: Endoscopic Tissue Approximation Device
510(k) Number: K171886
Device Name: OverStitch SX Endoscopic Suturing System (ESS)
Applicant: Apollo Endosurgery, Inc.
Regulation Number: 876.1500
Classification Product Code: OCW
Date Received: 06/26/2017
Decision Date: 11/15/2017
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Gastroenterology/Urology
510k Review Panel: General & Plastic Surgery
Total number of pages: 4,071
Fully redacted pages: 3,686
Content pages: 385
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