EVIS EXERA 160A SYSTEM
FDA 510(k) clearance K051645 · decided 2005-10-13
Clearance details
- K-number
- K051645
- Device name
- EVIS EXERA 160A SYSTEM
- Applicant
- Olympus Medical Systems Corporation
- Decision
- Substantially Equivalent
- Date received
- 2005-06-20
- Decision date
- 2005-10-13
- Days to decision
- 115 days
- Clearance type
- Traditional
- Product code
- NWB
- 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 |
|---|---|---|
| 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 |