CystoFlex UHD R-C, CelioFlex UHD 5-C, Cellvizio 100 Series (800) with Confocal Miniprobes
FDA 510(k) clearance K160416 · decided 2016-05-20
Clearance details
- K-number
- K160416
- Device name
- CystoFlex UHD R-C, CelioFlex UHD 5-C, Cellvizio 100 Series (800) with Confocal Miniprobes
- Applicant
- Mauna Kea Technologies
- Decision
- Substantially Equivalent
- Date received
- 2016-02-16
- Decision date
- 2016-05-20
- Days to decision
- 94 days
- Clearance type
- Special
- Product code
- OWN
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Paris, FR
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.