Cellvizio 100 Series System with Confocal Miniprobes
FDA 510(k) K111047 · Mauna Kea Technologies, Inc.
510(k) numberK111047
Submission
- Device name
- Cellvizio 100 Series System with Confocal Miniprobes
- Applicant
- Mauna Kea Technologies, Inc.
Newton, PA, US - Received
- April 15, 2011
- Decision date
- August 8, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
Device classification
- Product code
- OWN – Confocal Optical Imaging
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
Collection of light signals for visualization of cellular microstructures.
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More from Samantree Medical SA
| 510(k) | Device | Decision |
|---|---|---|
| K220477 | Cellvizio 100 series system with confocal MiniprobesOWN · Traditional | 04/11/2022SE |
| K212322 | Cellvizio I.V.E. system with Confocal MiniprobesOWN · Special | 08/18/2021SE |
| K193416 | Cellvizio I.V.E. with Confocal MiniprobesOWN · Traditional | 02/28/2020SE |
| K191144 | Cellvizio 100 Series System with Confocal MiniprobesOWN · Traditional | 01/24/2020SE |
| K183640 | Cellvizio 100 Series Confocal laser Imaging systems and their Confocal MiniprobesOWN · Special | 02/22/2019SE |
| K180270 | Cellvizio 100 Series Systems with Confocal MiniprobesGWG · Traditional | 05/22/2018SE |
| K172844 | Cellvizio 100 Series System with Confocal MiniprobesOWN · Traditional | 12/15/2017SE |
| K171345 | Cellvizio 100 Series Systems with Confocal MiniprobesOWN · Traditional | 08/04/2017SE |
| K160416 | CystoFlex UHD R-C, CelioFlex UHD 5-C, Cellvizio 100 Series (800) with Confocal MiniprobesOWN · Special | 05/20/2016SE |
| K150831 | Cellvizio 100 Series System with Confocal MiniprobesOWN · Traditional | 12/22/2015SE |
Questions and answers
When was Cellvizio 100 Series System with Confocal Miniprobes cleared by the FDA?
Cellvizio 100 Series System with Confocal Miniprobes (K111047) received a 510(k) decision of Substantially Equivalent on August 8, 2011, 115 days after the submission was received.
What is the product code of K111047?
The FDA product code is OWN – Confocal Optical Imaging, a Class II (moderate risk) device regulated under 21 CFR 876.1500.