FDA 510(k)
FDA class 2
Substantially Equivalent
🇫🇷 France
Cellvizio 100 Series System with Confocal Miniprobes
K Number: K150831
·
Decision Dec 22, 2015
Classifications
1
FEI Numbers
47
Registration Numbers
47
Same Product Code
60
Applicant Total
18
Review Days
267
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Basic Information
- Device Name
- Cellvizio 100 Series System with Confocal Miniprobes
- K Number
- K150831
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Mauna Kea Technologies
- Date Received
- March 30, 2015
- Decision Date
- December 22, 2015
- Product Code
- OWN
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- SU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| OWN | Confocal Optical Imaging | FDA class 2 | Gastroenterology, Urology |
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Other Clearances by Mauna Kea Technologies
| K Number | Device Name | ||
|---|---|---|---|
| K220477 | Cellvizio 100 series system with confocal Miniprobes | Apr 11, 2022 | Substantially Equivalent |
| K212322 | Cellvizio I.V.E. system with Confocal Miniprobes | Aug 18, 2021 | Substantially Equivalent |
| K193416 | Cellvizio I.V.E. with Confocal Miniprobes | Feb 28, 2020 | Substantially Equivalent |
| K191144 | Cellvizio 100 Series System with Confocal Miniprobes | Jan 24, 2020 | Substantially Equivalent |
| K183640 | Cellvizio 100 Series Confocal laser Imaging systems and their Confocal Miniprobes | Feb 22, 2019 | Substantially Equivalent |
| K180270 | Cellvizio 100 Series Systems with Confocal Miniprobes | May 22, 2018 | Substantially Equivalent |
| K172844 | Cellvizio 100 Series System with Confocal Miniprobes | Dec 15, 2017 | Substantially Equivalent |
| K171345 | Cellvizio 100 Series Systems with Confocal Miniprobes | Aug 4, 2017 | Substantially Equivalent |
| K160416 | CystoFlex UHD R-C, CelioFlex UHD 5-C, Cellvizio 100 Series (800) with Confocal Miniprobes | May 20, 2016 | Substantially Equivalent |
| K151593 | Cellvizio 100 Series System with Confocal Miniprobes | Oct 23, 2015 | Substantially Equivalent |