EVIS EXERA II DUODENOVIDEOSCOPE OLYMPUS TJF TYPE Q180V
FDA 510(k) clearance K143153 · decided 2016-01-15
Clearance details
- K-number
- K143153
- Device name
- EVIS EXERA II DUODENOVIDEOSCOPE OLYMPUS TJF TYPE Q180V
- Applicant
- Olympus Medical Systems Corp.
- Decision
- Substantially Equivalent
- Date received
- 2014-11-03
- Decision date
- 2016-01-15
- Days to decision
- 438 days
- Clearance type
- Traditional
- Product code
- FDT
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Hachioji-Shi, JP
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Olympus Medical Systems Corp.
The Builder collects up to 8 candidate devices side by side with yours, then exports the substantial-equivalence comparison scaffold. How it works
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Duodenovideoscope-EndoTherapy accessories (such as a biopsy forceps), and other ancillary recall (Z-0346-2024) | Aizu Olympus Co., Ltd. | 2023-11-17 |
| EVIS EXERA II DUODENOVIDEOSCOPE OLYMPUS TJF-Q180V Model Number: TJF-Q180V recall (Z-0379-2022) | Olympus Corporation of the Americas | 2021-12-10 |