EVIS EXERAII 180 SYSTEM
FDA 510(k) clearance K100584 · decided 2010-07-02
Clearance details
- K-number
- K100584
- Device name
- EVIS EXERAII 180 SYSTEM
- Applicant
- Olympus Medical Systems Corporation
- Decision
- Substantially Equivalent
- Date received
- 2010-03-02
- Decision date
- 2010-07-02
- Days to decision
- 122 days
- Clearance type
- Traditional
- Product code
- NWB
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Center Valley, PA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Colonoscope, Model Number CF-H180AL. recall (Z-1205-2024) | Olympus Corporation of the Americas | 2024-02-29 |
| Colonoscope, Model Number CF-Q180AL. recall (Z-1208-2024) | Olympus Corporation of the Americas | 2024-02-29 |
| Colonoscope, Model Number PCF-H180AL. recall (Z-1209-2024) | Olympus Corporation of the Americas | 2024-02-29 |
| Colonoscope, Model Number PCF-Q180AL. recall (Z-1214-2024) | Olympus Corporation of the Americas | 2024-02-29 |
| Colonoscope: for endoscopy and endoscopic surgery within the lower digestive tract (includ recall (Z-0329-2024) | Aizu Olympus Co., Ltd. | 2023-11-17 |
| Gastrointestinal videoscope-indicated for use within the upper digestive tract (including recall (Z-0334-2024) | Aizu Olympus Co., Ltd. | 2023-11-17 |
| EVIS EXERA III Colonovideoscope-For endoscopy and endoscopic surgery within the lower dige recall (Z-1132-2023) | Olympus Corporation of the Americas | 2023-02-13 |