V1 SYSTEM
FDA 510(k) clearance K111756 · decided 2012-03-20
Clearance details
- K-number
- K111756
- Device name
- V1 SYSTEM
- Applicant
- Olympus Medical Systems Corp.
- Decision
- Substantially Equivalent
- Date received
- 2011-06-22
- Decision date
- 2012-03-20
- Days to decision
- 272 days
- Clearance type
- Traditional
- Product code
- FDF
- 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: 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 |