EVIS EXERA GASTROINTESTINAL VIDEOSCOPE GIF-Q160Z
FDA 510(k) clearance K011151 · decided 2001-05-15
Clearance details
- K-number
- K011151
- Device name
- EVIS EXERA GASTROINTESTINAL VIDEOSCOPE GIF-Q160Z
- Applicant
- The Olympus Optical Co.
- Decision
- Substantially Equivalent
- Date received
- 2001-04-16
- Decision date
- 2001-05-15
- Days to decision
- 29 days
- Clearance type
- Special
- Product code
- FDS
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Melville, NY, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Gastrointestinal videoscope-indicated for use within the upper digestive tract (including recall (Z-0334-2024) | Aizu Olympus Co., Ltd. | 2023-11-17 |