EG-3870UTK
FDA 510(k) clearance K090197 · decided 2009-05-19
Clearance details
- K-number
- K090197
- Device name
- EG-3870UTK
- Applicant
- Pentax Medical Company
- Decision
- Substantially Equivalent
- Date received
- 2009-01-27
- Decision date
- 2009-05-19
- Days to decision
- 112 days
- Clearance type
- Traditional
- Product code
- ODG
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Montvale, NJ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| EG-3870UTK, Pentax Ultrasound Video Gastroscope. The EG-3870UTK, Ultrasound Video Gastrosc recall (Z-1489-2012) | Pentax Medical Company | 2012-05-03 |