EVIS Exera III Gastrointestinal Videoscope GIF-1TH190
FDA 510(k) clearance K232997 · decided 2024-06-19
Clearance details
- K-number
- K232997
- Device name
- EVIS Exera III Gastrointestinal Videoscope GIF-1TH190
- Applicant
- Olympus Medical Systems Corporation
- Decision
- Substantially Equivalent
- Date received
- 2023-09-22
- Decision date
- 2024-06-19
- Days to decision
- 271 days
- Clearance type
- Traditional
- Product code
- FDS
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Tokyo, JP
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| EVIS EXERA III Gastrointestinal Videoscope GIF-1TH190. Model Number: GIF-1TH190 recall (Z-0620-2025) | Olympus Corporation of the Americas | 2024-12-05 |
| Brand Name: EVIS EXERA III Gastrointestinal Videoscope GIF-1TH190 Product Name: Olympus GI recall (Z-0498-2025) | Olympus Corporation of the Americas | 2024-11-20 |