USGI Transport Endoscopic Access Device
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
by USGI Medical
Identifiers
- 510(k) Number
- K072405 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 USGI Transport Endoscopic Access Device is an Endoscopic Access Overtube, classified under Gastroenterology and Urology. It serves as a flexible, steerable platform designed to facilitate endoscopic procedures by providing stable access to the gastrointestinal tract. The device incorporates multiple lumens for instrument insertion and exchange, enabling precise manipulation of endoscopic tools within the operating site.
This device is supplied as a two-part system featuring a flexible shaft with a rigidizing and locking mechanism, along with a steerable tip. It is intended for single-use applications and has received FDA 510(k) clearance and MDD authorization. The device is not MRI-safe and must be stored in accordance with manufacturer guidelines to maintain sterility and functionality. Its design allows for intuitive handling, resembling conventional endoscope controls, to enhance procedural stability and visualization.
Frequently asked questions
What medical specialties is the USGI Transport Endoscopic Access Device primarily used in, and why is it designed this way?
The USGI Transport Endoscopic Access Device is primarily used in Gastroenterology and Urology, as explicitly stated in its classification. It is designed this way because it serves as a flexible, steerable platform to facilitate endoscopic procedures in both specialties, providing stable access to the gastrointestinal tract while accommodating the precise manipulation of tools required in these fields.
Is the USGI Transport Endoscopic Access Device intended for reuse, or is it meant to be used only once?
The device is explicitly designed for single-use applications, as mentioned in the description. This ensures patient safety and sterility, as it is not intended to be reused after a single procedure.
How is the USGI Transport Endoscopic Access Device supplied, and what features does it include?
The device is supplied as a two-part system consisting of a flexible shaft with a rigidizing and locking mechanism, along with a steerable tip. This design allows for intuitive handling, similar to conventional endoscope controls, enhancing procedural stability and visualization during use.
Can the USGI Transport Endoscopic Access Device be used in an MRI environment, and what storage guidelines should be followed?
The device is not MRI-safe, so it should never be used in an MRI environment. It must be stored in accordance with the manufacturer’s guidelines to maintain both sterility and functionality, as specified in the device description.
What regulatory pathways has the USGI Transport Endoscopic Access Device undergone, and what does this mean for its use?
The device has received FDA 510(k) clearance and MDD authorization, confirming its compliance with U.S. and European regulatory standards. This means it has been evaluated for safety and effectiveness and can be legally marketed and used in the respective regions under these regulatory frameworks.
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: Products — USGI Medical Website, USGI Medical, Inc. - endolumenalsurgery.com, USGI TRANSPORT ENDOSCOPIC ACCESS DEVICE (K072405) — FDA 510 (k ...
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K072405 | Class II | Active |
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Manufacturer
- Manufacturer
- USGI Medical
Sources (2)
- FDA 510(k) K072405 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026