Overstitch Endoscopic Suture System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K081853 FDA 510(k)
- FDA Product Code
- OCW FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 876.1500 FDA 510(k)
- Regulation Number
- 876.1500 FDA 510(k)
- Advisory Committee
- Gastroenterology, Urology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Overstitch Endoscopic Suturing System is an Endoscopic Tissue Approximation Device, designed to facilitate precise, full-thickness suturing of soft tissues during endoscopic procedures. It enables the placement of durable, customizable suture patterns to create stable tissue constructs, supporting minimally invasive repairs in gastroenterology and urology applications.
This system is intended for single-use in controlled clinical settings, such as endoscopy suites or operating rooms, and is supplied sterile. It is classified as a Class II device under FDA regulations (876.1500) and has received FDA 510K clearance for substantial equivalence. Multiple model references (e.g., Ess-G02-160) are available, with compatibility confirmed for MRI-safe environments. Storage requires adherence to manufacturer guidelines to maintain sterility and functionality.
Frequently asked questions
What types of procedures is the Overstitch Endoscopic Suturing System designed to assist with, and in which specialties is it commonly used?
The Overstitch Endoscopic Suturing System is designed for endoscopic procedures requiring precise, full-thickness suturing of soft tissues. It is primarily used in gastroenterology and urology applications to create stable tissue repairs, such as those needed for minimally invasive surgeries. The system enables customizable suture patterns to support repairs like leak closures or tissue reconstructions in controlled clinical settings like endoscopy suites or operating rooms.
Is the Overstitch Endoscopic Suturing System intended for reuse, or is it meant to be used only once per patient?
The Overstitch Endoscopic Suturing System is explicitly designed for single-use only in controlled clinical settings. This ensures sterility and safety for each patient, as reusing the device could compromise its integrity and introduce infection risks. The system is supplied sterile, so it must remain unopened until use.
What storage requirements must be followed to maintain the device’s sterility and functionality?
To preserve sterility and functionality, the Overstitch Endoscopic Suturing System must be stored according to the manufacturer’s guidelines. Since it is supplied sterile, it should remain in its original packaging until ready for use, protected from contamination, moisture, and physical damage. Avoid exposure to extreme temperatures or direct sunlight, as these could degrade the device’s components.
Are there different model references available, and how do I determine which one is compatible with my procedure?
Yes, multiple model references (e.g., Ess-G02-160) are available for the Overstitch system. The specific model should be selected based on the intended application and compatibility with your endoscopic equipment. While the system is designed for general use in gastroenterology and urology, confirming the exact model’s suitability for your procedure—such as suture length or tissue type—requires consulting the manufacturer’s documentation or technical support.
Can the Overstitch Endoscopic Suturing System be used in an MRI environment, and if so, is it considered MRI-safe?
Yes, the Overstitch Endoscopic Suturing System is compatible with MRI-safe environments. The manufacturer has confirmed that the materials and design of the system meet MRI safety standards, allowing for use in facilities where MRI imaging may be required before or after the procedure. Always verify the specific model’s MRI safety documentation if this is a critical consideration for your workflow.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: apollo endosurgery OverStitch Sx Instructions For Use Manual, OverStitch™ Endoscopic Suturing System - Boston Scientific, PDF OverStitch™ Endoscopic Suturing Syst - bostonscientific.com, OverStitch™ series - Laparoscopic suturing endoscopic surgical system ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K081853 | Class II | Active |
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Manufacturer
- Manufacturer
- Apollo Endosurgery, Inc.
Sources (1)
- FDA 510(k) K081853 24 fields · synced Sep 19, 2026