EVIS EXERA III VIDEO SYSTEM
FDA 510(k) clearance K131780 · decided 2013-08-29
Clearance details
- K-number
- K131780
- Device name
- EVIS EXERA III VIDEO SYSTEM
- Applicant
- Olympus Medical Systems Corp.
- Decision
- Substantially Equivalent
- Date received
- 2013-06-17
- Decision date
- 2013-08-29
- Days to decision
- 73 days
- Clearance type
- Special
- 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 |
|---|---|---|
| EVIS EXERA III Video System Center Model Number CV-190. Intended to be used with OLYMPUS c recall (Z-0056-2025) | Olympus Corporation of the Americas | 2024-10-11 |
| Colonoscope, Model Number PCF-H190DL. recall (Z-1210-2024) | Olympus Corporation of the Americas | 2024-02-29 |
| CF-HQ190L EVIS EXERA III COLONOVIDEOSCOPE recall (Z-0415-2024) | Aizu Olympus Co., Ltd. | 2023-11-29 |
| GIF-H190, EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE recall (Z-0416-2024) | Aizu Olympus Co., Ltd. | 2023-11-29 |
| GIF-HQ190, EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE recall (Z-0417-2024) | Aizu Olympus Co., Ltd. | 2023-11-29 |
| PCF-H190DL, EVIS EXERA III COLONOVIDEOSCOPE recall (Z-0418-2024) | Aizu Olympus Co., Ltd. | 2023-11-29 |
| PCF-H190L, EVIS EXERA III COLONOVIDEOSCOPE recall (Z-0419-2024) | Aizu Olympus Co., Ltd. | 2023-11-29 |
| Colonoscope-indicated for use within the lower digestive tract (including the anus, rectum recall (Z-0341-2024) | Aizu Olympus Co., Ltd. | 2023-11-17 |