K192266 is an FDA 510(k) clearance for the M. Blue Adjustable Shunt System. This device is classified as a Shunt, Central Nervous System And Components (Class II - Special Controls, product code JXG).
Submitted by Aesculap, Inc. (Center Valley, US). The FDA issued a Cleared decision on November 21, 2019, 92 days after receiving the submission on August 21, 2019.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5550.
| 510(k) Number | K192266 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 21, 2019 |
| Decision Date | November 21, 2019 |
| Days to Decision | 92 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | JXG — Shunt, Central Nervous System And Components |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.5550 |