FDA 510(k) K231553, OverStitch NXT Endoscopic Suturing System, by Apollo Endosurgery, Inc.

FDA 510(k) K231553, OverStitch NXT Endoscopic Suturing System, by Apollo Endosurgery, Inc.

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Device Classification Name: Endoscopic Tissue Approximation Device
510(k) Number: K231553
Device Name: OverStitch NXT Endoscopic Suturing System
Applicant: Apollo Endosurgery, Inc.
Regulation Number: 876.1500
Classification Product Code: OCW
Date Received: 05/30/2023
Decision Date: 06/29/2023
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Gastroenterology/Urology
510k Review Panel: General & Plastic Surgery

Total number of pages: 554
Fully redacted pages: 227
Content pages: 327

PLEASE NOTE: Most 510(k)s obtained through FOIA are heavily redacted, often omitting sections related to testing, software, manufacturing, and other technical data. Please be sure to review the total pages, redacted pages, and content pages listed in the description to get a sense of how much of the document is redacted. As the FDA FOIA office explains: “We HEAVILY REDACT the majority of the following portions of 510(k) filings: testing data, technical data, lab reports, manufacturing information, vendor information, substantive discussions regarding deficiencies or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.” If you’d like more details about a specific document before purchasing, please contact us at info@foiadocs.com.

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