SMALL INTESTINAL VIDEOSCOPE SYSTEM
FDA 510(k) clearance K071254 · decided 2008-03-25
Clearance details
- K-number
- K071254
- Device name
- SMALL INTESTINAL VIDEOSCOPE SYSTEM
- Applicant
- Olympus Medical Systems Corporation
- Decision
- Substantially Equivalent
- Date received
- 2007-05-04
- Decision date
- 2008-03-25
- Days to decision
- 326 days
- Clearance type
- Traditional
- Product code
- FDA
- 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 |
|---|---|---|
| Small intestinal videoscope-For endoscopy and endoscopic surgery within the upper digestiv recall (Z-0343-2024) | Aizu Olympus Co., Ltd. | 2023-11-17 |