ESOPHYX2 HD
FDA 510(k) clearance K142113 · decided 2014-09-30
Clearance details
- K-number
- K142113
- Device name
- ESOPHYX2 HD
- Applicant
- Endogastric Solutions, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2014-08-04
- Decision date
- 2014-09-30
- Days to decision
- 57 days
- Clearance type
- Special
- Product code
- ODE
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Gardnerville, NV, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.