OLYMPUS TJF-140R/JF-140R EVIS DUODENOVIDEOSCOPES AND ACCESSORIES, OLYMPUS MAJ-311/MAJ-411 DISTAL COVERS
FDA 510(k) clearance K980465 · decided 1998-04-21
Clearance details
- K-number
- K980465
- Device name
- OLYMPUS TJF-140R/JF-140R EVIS DUODENOVIDEOSCOPES AND ACCESSORIES, OLYMPUS MAJ-311/MAJ-411 DISTAL COVERS
- Applicant
- Olympus America, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1998-02-05
- Decision date
- 1998-04-21
- Days to decision
- 75 days
- Clearance type
- Traditional
- Product code
- FDT
- 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
+ Add to Predicate Builder ◉ Watch Olympus America
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 |
|---|---|---|
| Colonoscope-indicated for use within the lower digestive tract (including the anus, rectum recall (Z-0341-2024) | Aizu Olympus Co., Ltd. | 2023-11-17 |
| Signmoidovideoscope-For endoscopy and endoscopic surgery within the lower digestive tract recall (Z-0342-2024) | Aizu Olympus Co., Ltd. | 2023-11-17 |