K180270 is an FDA 510(k) clearance for the Cellvizio 100 Series Systems with Confocal Miniprobes. This device is classified as a Endoscope, Neurological (Class II - Special Controls, product code GWG).
Submitted by Mauna Kea Technologies (Paris, FR). The FDA issued a Cleared decision on May 22, 2018, 111 days after receiving the submission on January 31, 2018.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.1480. If The Device Is Reusable, Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission (82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf)..
| 510(k) Number | K180270 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 31, 2018 |
| Decision Date | May 22, 2018 |
| Days to Decision | 111 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | GWG - Endoscope, Neurological |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.1480 |
| Definition | If The Device Is Reusable, Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission (82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf). |