ENDOGASTRIC STOMAPHYX DEVICE AND ACCESSORIES— 510(k) K062875
Substantially EquivalentEndogastric Solutions, Inc.
FDA 510(k) clearance K062875 for ENDOGASTRIC STOMAPHYX DEVICE AND ACCESSORIES, Substantially Equivalent on 2007-03-09. Applicant: Endogastric Solutions, Inc.. Device class: 2.
Clearance details
- Applicant
- Endogastric Solutions, Inc.
- Product code
- Code OCW
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Redmond, WA, US
Recent devices under product code OCW
view allMore clearances from Endogastric Solutions, Inc.
view all- K240879 — EsophyX Z+ Device with SerosaFuse Fasteners and Accessories
- K172811 — EsophyX Z, EsophyX2 HD
- K171307 — EsophyX2 HD Device with SerosaFuse Fasteners and Accessories, EsophyX Z Device with SerosaFuse Fasteners and Accessories
- K160960 — EsophyX® Z Device with SerosaFuse Fasteners and Accessories
- K143645 — EsophyX® Z Fastener Delivery Device
Adverse events under product code OCW
product code OCW- Death
- 6
- Injury
- 443
- Malfunction
- 1,023
- Other
- 2
- Total
- 1,474
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.