Evis Exera III Colonovideoscope Olympus PCF-H190TL, Evis Exera III Colonovideoscope Olympus PCF-H190TI, Evis Exera III Colonovideoscope Olympus PCF-HQ190L, Evis Exera III Colonovideoscope Olympus PCF-HQ190I
FDA 510(k) clearance K192793 · decided 2020-07-17
Clearance details
- K-number
- K192793
- Device name
- Evis Exera III Colonovideoscope Olympus PCF-H190TL, Evis Exera III Colonovideoscope Olympus PCF-H190TI, Evis Exera III Colonovideoscope Olympus PCF-HQ190L, Evis Exera III Colonovideoscope Olympus PCF-HQ190I
- Applicant
- Olympus Medical Systems Corp.
- Decision
- Substantially Equivalent
- Date received
- 2019-09-30
- Decision date
- 2020-07-17
- Days to decision
- 291 days
- Clearance type
- Traditional
- Product code
- FDF
- 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
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Colonoscope, Model Number PCF-H190TL. recall (Z-1212-2024) | Olympus Corporation of the Americas | 2024-02-29 |
| Colonoscope, Model Number PCF-HQ190L. recall (Z-1213-2024) | Olympus Corporation of the Americas | 2024-02-29 |
| Colonoscope-indicated for use within the lower digestive tract (including the anus, rectum recall (Z-0341-2024) | Aizu Olympus Co., Ltd. | 2023-11-17 |