FDA 510(k)

Intellidrop

K-Number: K251598 · 2025-12-10

Decision Date2025-12-10

Product CodeJXG

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

Intellidrop is a medical device manufactured by Brainspace, Inc.. It received FDA 510(k) clearance on 2025-12-10 under approval number K251598. The device is classified under product code JXG. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Intellidrop?

Intellidrop is a medical device that received FDA 510(k) clearance on 2025-12-10. It is manufactured by Brainspace, Inc.. The 510(k) number is K251598.

When was Intellidrop approved by the FDA?

Intellidrop received FDA 510(k) clearance on 2025-12-10, under approval number K251598.

What company makes Intellidrop?

Intellidrop is manufactured by Brainspace, Inc..

What is the FDA product code for Intellidrop?

The FDA product code for Intellidrop is JXG.

Related Devices (Code: JXG)

K162437Codman EDS3 CSF External Drainage SystemCodman & Shurtleff, Inc. K161605Smart External Drain (SED) SystemAqueduct Critical Care, Inc. K161992Horizontal-Vertical Lumbar Valve Systems, Spetzler Lumbar Peritoneal Shunt SystemsIntegra LifeSciences Corporation K152700StrataMR Valves and ShuntsMedtronic Neurosurgery K153041Bundled Neurological Shunts and Accessories Product Families Labeling Modification to Support MR Conditional LabelingIntegra LifeSciences Corporation K152897Integra DP Valve Systems (including Burr Hole Reservoirs and Stainless Steel Connectors), Gravity Compensating AccessoryIntegra LifeSciences Corporation

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.