K191684 is an FDA 510(k) clearance for the MoniTorr ICP External Drainage and Monitoring System, LimiTorr Volume Limiting External CSF Drainage System. This device is classified as a Shunt, Central Nervous System And Components (Class II - Special Controls, product code JXG).
Submitted by Integra LifeSciences Corporation (Planisboro, US). The FDA issued a Cleared decision on October 11, 2019, 109 days after receiving the submission on June 24, 2019.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5550.
| 510(k) Number | K191684 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 24, 2019 |
| Decision Date | October 11, 2019 |
| Days to Decision | 109 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 |