Usgi Transport Endoscopic Guide
FDA 510(k) K061216 · Usgi Medical
510(k) numberK061216
Submission
- Device name
- Usgi Transport Endoscopic Guide
- Applicant
- Usgi Medical
San Clemente, CA, US - Received
- May 2, 2006
- Decision date
- May 15, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- FED – Endoscopic Access Overtube, Gastroenterology-Urology
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
To facilitate passage and aid advancement of endoscopes into the body, especially in cases of repeated intubation.
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| K252572 | Prodeon Urethral Sheath SystemFED · Traditional | Prodeon Medical, Inc. | 10/07/2025SE |
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| K250132 | Ureteral Access SheathFED · Traditional | Zhejiang YiGao Medical Technology Co., Ltd. | 09/05/2025SE |
| K250695 | Single-use Ureteral Access SheathFED · Traditional | Shenzhen HugeMed Medical Technical Development… | 07/08/2025SE |
| K251599 | Single-use Ureteral Access SheathFED · Special | Hunan Vathin Medical Instrument Co., Ltd. | 07/03/2025SE |
| K250585 | LumenaTM Ureteral Access SheathFED · Traditional | Cathegenix (Xiamen) Co., Ltd. | 06/27/2025SE |
More from Cathegenix (Xiamen) Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K103688 | G-Prox Ez Endoscopic GrasperOCZ · Special | 01/14/2011SE |
| K102931 | G-Cinch Suture GrasperOCW · Traditional | 12/30/2010SE |
| K102916 | G-Cath Tissue Anchor Delivery CatheterGAT · Special | 10/20/2010SE |
| K100251 | G-Cath Tissue Anchor Delivery Catheter, Models 205302, 205333GAT · Special | 02/17/2010SE |
| K093018 | G-Prox Endoscopic Grasper, Model 205333GAT · Special | 10/07/2009SE |
| K072405 | Usgi Transport Endoscopic Access DeviceFED · Special | 09/13/2007SE |
| K061276 | G-Prox Endoscopic GrasperGAT · Traditional | 12/06/2006SE |
| K061268 | G-Lix Tissue GrasperHET · Traditional | 07/31/2006SE |
| K051919 | Modification to: Usgi Shapelock Endoscopic GuideFED · Special | 07/26/2005SE |
| K050253 | Usgi Shapelock Endoscopic GuideFED · Special | 02/28/2005SE |
Questions and answers
When was Usgi Transport Endoscopic Guide cleared by the FDA?
Usgi Transport Endoscopic Guide (K061216) received a 510(k) decision of Substantially Equivalent on May 15, 2006, 13 days after the submission was received.
What is the product code of K061216?
The FDA product code is FED – Endoscopic Access Overtube, Gastroenterology-Urology, a Class II (moderate risk) device regulated under 21 CFR 876.1500.