Monitorr Icp External Drainage and Monitoring Systems
FDA 510(k) K062599 · Integra LifeSciences Corporation
510(k) numberK062599
Submission
- Device name
- Monitorr Icp External Drainage and Monitoring Systems
- Applicant
- Integra LifeSciences Corporation
Plainsboro, NJ, US - Received
- September 1, 2006
- Decision date
- September 27, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code JXG
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261004 | Codman® Distal Peritoneal Catheter, Barium Open End (82-1682); Codman® HOLTER®…JXG · Traditional | Integra Lifesciences Production Corporation | 06/23/2026SE |
| K251598 | IntellidropJXG · Traditional | Brainspace, Inc. | 12/10/2025SE |
| K250636 | Sophy Mini Monopressure Valve (SM1)JXG · Traditional | Sophysa | 11/28/2025SE |
| K252514 | Evac-MriJXG · Traditional | Phasor Health, LLC | 11/05/2025SESD |
| K243531 | Codman Libertís Shunt Catheter with Bactiseal and Endexo TechnologyJXG · Traditional | Integra Lifesciences Production Corporation | 08/08/2025SE |
| K243552 | Codman Libertís 1.5 mm EVD Catheter with Bactiseal® and Endexo® Technology with Luer…JXG · Traditional | Integra Lifesciences Production Corporation | 08/06/2025SE |
| K242974 | External CSF Drainage Ventricular Catheters, External CSF Drainage Lumbar CathetersJXG · Traditional | Sophysa | 06/20/2025SE |
| K243205 | EvacJXG · Traditional | Phasor Health, LLC | 06/03/2025SE |
| K243676 | Duet External Drainage and Monitoring System (EDMS)JXG · Traditional | Medtronic Neurosurgery | 03/10/2025SE |
| K242003 | XABO Ventricular Catheter, XABO Peritoneal Catheter, XABO Catheter SetJXG · Traditional | Aesculap, Inc. | 12/16/2024SE |
More from Aesculap, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K251162 | CUSA® Clarity Ultrasonic Surgical Aspirator SystemLFL · Traditional | 10/08/2025SE |
| K250752 | AURORA® Surgiscope® System (ASX15/60); AURORA® Surgiscope® System (ASX15/80)GWG · Special | 04/09/2025SE |
| K240493 | CUSA® Clarity Ultrasonic Surgical Aspirator SystemLFL · Traditional | 07/11/2024SE |
| K230427 | CUSA Clarity Ultrasonic Surgical Aspirator SystemLFL · Traditional | 07/11/2023SE |
| K221835 | CUSA Clarity Ultrasonic Surgical Aspirator SystemLFL · Traditional | 08/22/2022SE |
| K221763 | CUSA Clarity Ultrasonic Surgical Aspirator SystemLFL · Special | 07/15/2022SE |
| K210128 | INTEGRA Wound Matrix (Macro-Channels)KGN · Traditional | 10/08/2021SE |
| K210016 | Integra DigiFuse Cannulated Intramedullary Fusion System,Integra Total Foot…HRS · Traditional | 07/27/2021SE |
| K193346 | Codman Surgical Patties & StripsHBA · Traditional | 11/20/2020SE |
| K201507 | Cadence Total Ankle SystemHSN · Special | 06/29/2020SE |
Questions and answers
When was Monitorr Icp External Drainage and Monitoring Systems cleared by the FDA?
Monitorr Icp External Drainage and Monitoring Systems (K062599) received a 510(k) decision of Substantially Equivalent on September 27, 2006, 26 days after the submission was received.
What is the product code of K062599?
The FDA product code is JXG – Shunt, Central Nervous System And Components, a Class II (moderate risk) device regulated under 21 CFR 882.5550.