Overtube Endoscopic Access System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K122270 FDA 510(k)
- FDA Product Code
- FED 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 Overtube Endoscopic Access System is an endoscopic access overtube designed to protect the esophagus during various endoscopic procedures. It facilitates the passage of endoscopes and provides a protective conduit for instrumentation.
This device is manufactured by Apollo Endosurgery, Inc. and has received FDA 510k clearance. Users should consult the provided instructions for use for information regarding clinical application, compatibility, and safety protocols.
Frequently asked questions
What is the primary purpose of the Overtube Endoscopic Access System?
This device is designed to protect the esophagus during various endoscopic procedures. It serves as a protective conduit that facilitates the safe passage of endoscopes and associated instrumentation.
Who is the manufacturer of this endoscopic access system?
The Overtube Endoscopic Access System is manufactured by Apollo Endosurgery, Inc., based in Austin, Texas.
What is the regulatory status of this device?
The Overtube Endoscopic Access System has received FDA 510k clearance. This indicates that the device has been reviewed and found to be substantially equivalent to legally marketed predicate devices.
Where can I find specific instructions for clinical use and safety?
Users should consult the provided instructions for use (IFU) document. The IFU contains essential information regarding the device's clinical application, compatibility with other equipment, and required safety protocols.
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: OverTube - Apollo Endosurgery - PDF Catalogs | Technical Documentation, APOLLO ENDOSURGERY OVERTUBE USER MANUAL Pdf Download, PDF OverTube O - bostonscientific.com, Laparoscopic trocar sleeve - OverTube™ - Apollo Endosurgery
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K122270 | Class II | Active |
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Manufacturer
- Manufacturer
- Apollo Endosurgery, Inc.
Sources (1)
- FDA 510(k) K122270 24 fields · synced Sep 25, 2026