Fuse Endoscopic System with FuseBox Processor
FDA 510(k) clearance K160275 · decided 2016-08-01
Clearance details
- K-number
- K160275
- Device name
- Fuse Endoscopic System with FuseBox Processor
- Applicant
- Endochoice, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2016-02-02
- Decision date
- 2016-08-01
- Days to decision
- 181 days
- Clearance type
- Traditional
- Product code
- PEA
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Alpharetta, GA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.