FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ENDOGASTRIC SOLUTIONS STOMAPHYX DEVICE AND ACCESSORIES
K Number: K073644
·
Decision Jun 27, 2008
Classifications
1
FEI Numbers
52
Registration Numbers
52
Same Product Code
69
Applicant Total
11
Review Days
184
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Basic Information
- Device Name
- ENDOGASTRIC SOLUTIONS STOMAPHYX DEVICE AND ACCESSORIES
- K Number
- K073644
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Endogastric Solutions, Inc.
- Date Received
- December 26, 2007
- Decision Date
- June 27, 2008
- Product Code
- OCW
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| OCW | Endoscopic Tissue Approximation Device | FDA class 2 | Gastroenterology, Urology |
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Other Clearances by Endogastric Solutions, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K240879 | EsophyX Z+ Device with SerosaFuse Fasteners and Accessories | Apr 26, 2024 | Substantially Equivalent |
| K172811 | EsophyX Z, EsophyX2 HD | Oct 19, 2017 | Substantially Equivalent |
| K171307 | EsophyX2 HD Device with SerosaFuse Fasteners and Accessories, EsophyX Z Device with SerosaFuse Fasteners and Accessories | Jun 22, 2017 | Substantially Equivalent |
| K160960 | EsophyX® Z Device with SerosaFuse Fasteners and Accessories | May 1, 2016 | Substantially Equivalent |
| K143645 | EsophyX® Z Fastener Delivery Device | Mar 4, 2015 | Substantially Equivalent |
| K142113 | ESOPHYX2 HD | Sep 30, 2014 | Substantially Equivalent |
| K092400 | ENDOGASTRIC SOLUTIONS ESOPHYX2 SYSTEM WITH SEROSAFUSE FASTENER AND ACCESSORIES, MODEL 2.7.5 | Nov 6, 2009 | Substantially Equivalent |
| K091832 | ENDOGASTRIC SOLUTIONS STOMAPHYX SYSTEM WITH SEROSAFUSE FASTENER | Jul 22, 2009 | Substantially Equivalent |
| K071651 | EGS SEROSAFUSE IMPLANTABLE FASTENERS, ASSOCIATED DELIVERY DEVICES AND ACCESSORIES | Sep 14, 2007 | Substantially Equivalent |
| K062875 | ENDOGASTRIC STOMAPHYX DEVICE AND ACCESSORIES | Mar 9, 2007 | Substantially Equivalent |