USGI TransPort Endoscopic Guide
FDA 510(k)Class II (US FDA 510(k))
by USGI Medical
Identifiers
- 510(k) Number
- K061216 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 Guide is classified as an Endoscopic Access Overtube, designed to assist in gastrointestinal and urological procedures. It serves as a protective conduit and stabilising platform for endoscopes and flexible instruments, facilitating controlled navigation through the digestive or urinary tract while minimising trauma to tissue.
This device is intended for single-use and is supplied sterile, requiring no additional preparation before use. It is compatible with MRI environments and features a steerable design with lockable positioning to maintain stability during endoscopic procedures. Available in multiple sizes, it is regulated under FDA 510(k) clearance (K061216) and adheres to regulatory standards outlined in 876.1500. Authorised for use in gastroenterology and urology, it is distributed as a reusable accessory for endoscopic systems.
Frequently asked questions
What is the USGI TransPort Endoscopic Guide used for?
The USGI TransPort Endoscopic Guide is designed as an Endoscopic Access Overtube to assist in gastrointestinal and urological procedures. It acts as a protective conduit and stabilising platform for endoscopes and flexible instruments, helping to navigate the digestive or urinary tract more safely. Its steerable design and lockable positioning minimise tissue trauma during procedures, improving precision and control for clinicians.
Is the USGI TransPort Endoscopic Guide single-use or reusable?
The USGI TransPort Endoscopic Guide is explicitly designed for single-use only. This ensures sterility and reduces the risk of cross-contamination between patients. No additional preparation is required before use, as it is supplied sterile.
What sizes are available for the USGI TransPort Endoscopic Guide?
The USGI TransPort Endoscopic Guide is available in multiple sizes, as indicated by the extensive list of registration numbers (e.g., 3005173255, 3012649202, etc.). These variations cater to different procedural needs and patient anatomies. The manufacturer’s documentation or product catalog should specify exact dimensions and compatibility with specific endoscopic systems.
Can the USGI TransPort Endoscopic Guide be used in MRI environments?
Yes, the USGI TransPort Endoscopic Guide is compatible with MRI environments. This makes it suitable for procedures requiring imaging guidance without interference or safety concerns related to magnetic fields.
How should the USGI TransPort Endoscopic Guide be stored?
Since the device is single-use and sterile, it should be stored in its original packaging in a clean, dry environment, away from direct sunlight or extreme temperatures. Follow the manufacturer’s instructions for shelf-life and expiration dates to ensure optimal performance and sterility. Avoid contamination by keeping the packaging intact until immediate use.
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: USGI Medical Website, Products — USGI Medical Website, USGI TRANSPORT ENDOSCOPIC ACCESS DEVICE by USGI MEDICAL | FDA 510 (k ..., USGI TRANSPORT ENDOSCOPIC GUIDE (K061216) — FDA 510 (k) | Innolitics
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K061216 | Class II | Active |
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Manufacturer
- Manufacturer
- USGI Medical
Sources (1)
- FDA 510(k) K061216 24 fields · synced Oct 1, 2026