FUJINON/FUJIFILM ULTRASONIC ENDOSCOPE EG-530UR2 AND EG-530UT2
FDA 510(k) clearance K120446 · decided 2012-08-13
Clearance details
- K-number
- K120446
- Device name
- FUJINON/FUJIFILM ULTRASONIC ENDOSCOPE EG-530UR2 AND EG-530UT2
- Applicant
- Fujinon, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2012-02-14
- Decision date
- 2012-08-13
- Days to decision
- 181 days
- Clearance type
- Traditional
- Product code
- FDS
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Wayne, NJ, US
- Third-party review
- Yes
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Fujinon/Fujifilm Ultrasonic Endoscope Intended to provide ultrasonic images of submucosal recall (Z-0112-2014) | Fujinon Inc | 2013-10-30 |