Endogastric Solutions Stomaphyx System with Serosafuse Fastener
FDA 510(k) K091832 · Endogastric Solutions, Inc.
510(k) numberK091832
Submission
- Device name
- Endogastric Solutions Stomaphyx System with Serosafuse Fastener
- Applicant
- Endogastric Solutions, Inc.
Redmond, WA, US - Received
- June 22, 2009
- Decision date
- July 22, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OCW – Endoscopic Tissue Approximation Device
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
To aid in endoscopically placing sutures, staples, clips, and other fastening tools through tissue.
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| K211309 | endomina systemOCW · Traditional | Endo Tools Therapeutics S.A. | 12/07/2021SE |
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More from Apollo Endosurgery
| 510(k) | Device | Decision |
|---|---|---|
| K240879 | EsophyX Z+ Device with SerosaFuse Fasteners and AccessoriesODE · Special | 04/26/2024SE |
| K172811 | EsophyX Z, EsophyX2 HDODE · Traditional | 10/19/2017SE |
| K171307 | EsophyX2 HD Device with SerosaFuse Fasteners and Accessories, EsophyX Z Device with…ODE · Traditional | 06/22/2017SE |
| K160960 | EsophyX® Z Device with SerosaFuse Fasteners and AccessoriesODE · Special | 05/01/2016SE |
| K143645 | EsophyX® Z Fastener Delivery DeviceODE · Traditional | 03/04/2015SE |
| K142113 | ESOPHYX2 HDODE · Special | 09/30/2014SE |
| K092400 | Endogastric Solutions ESOPHYX2 System with Serosafuse Fastener and Accessories, Model…ODE · Special | 11/06/2009SE |
| K073644 | Endogastric Solutions Stomaphyx Device and AccessoriesOCW · Traditional | 06/27/2008SE |
| K071651 | Egs Serosafuse Implantable Fasteners, Associated Delivery Devices and AccessoriesODE · Traditional | 09/14/2007SE |
| K062875 | Endogastric Stomaphyx Device and AccessoriesOCW · Traditional | 03/09/2007SE |
Questions and answers
When was Endogastric Solutions Stomaphyx System with Serosafuse Fastener cleared by the FDA?
Endogastric Solutions Stomaphyx System with Serosafuse Fastener (K091832) received a 510(k) decision of Substantially Equivalent on July 22, 2009, 30 days after the submission was received.
What is the product code of K091832?
The FDA product code is OCW – Endoscopic Tissue Approximation Device, a Class II (moderate risk) device regulated under 21 CFR 876.1500.