FUSE COLONOSCOPY SYSTEM
FDA 510(k) clearance K141598 · decided 2014-09-30
Clearance details
- K-number
- K141598
- Device name
- FUSE COLONOSCOPY SYSTEM
- Applicant
- Endochoice, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2014-06-13
- Decision date
- 2014-09-30
- Days to decision
- 109 days
- Clearance type
- Special
- Product code
- FDF
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Caesarea, IL
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Fuse 1C Colonoscope recall (Z-0694-2016) | EndoChoice, Inc. | 2016-01-27 |