PENTAX ED-3490TK, VIDEO DUODENOSCOPE
FDA 510(k) clearance K092710 · decided 2009-12-02
Clearance details
- K-number
- K092710
- Device name
- PENTAX ED-3490TK, VIDEO DUODENOSCOPE
- Applicant
- Pentax Medical Company
- Decision
- Substantially Equivalent
- Date received
- 2009-09-03
- Decision date
- 2009-12-02
- Days to decision
- 90 days
- Clearance type
- Traditional
- Product code
- FDT
- 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 |
|---|---|---|
| Pentax Video Duodenoscope Model: ED-3490TK (UDI of design being recalled: 04961333232420) recall (Z-0643-2018) | Pentax of America Inc | 2018-02-20 |