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NICO BrainPath & Accessories, NICO BrainPath, NICO Shepherd's Hook

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K150378

by NICO Corporation

Identifiers

510(k) Number
K150378 FDA 510(k)
FDA Product Code
GZT FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 882.4800 FDA 510(k)
Regulation Number
882.4800 FDA 510(k)
Advisory Committee
Neurology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The NICO BrainPath & Accessories, NICO BrainPath, and NICO Shepherd's Hook are self-retaining retractors designed for neurosurgical procedures. These devices are engineered to provide precise exposure and retraction of brain tissue, facilitating access during cranial surgeries while minimizing trauma to surrounding structures.

Supplied as reusable instruments, these retractors are intended for use in sterile operating room environments. They are classified under FDA device class II and comply with the Medical Device Regulation (MDR) requirements. The product line includes multiple model references, each tailored for specific neurosurgical applications, and is authorized through FDA 510(k) clearance and MDR compliance.

Frequently asked questions

Are these retractors designed for single-use or can they be reused in multiple procedures?

The NICO BrainPath & Accessories, NICO BrainPath, and NICO Shepherd's Hook are explicitly labeled as reusable instruments. They are engineered for sterile operating room environments and intended to be reprocessed between uses, adhering to standard surgical instrument sterilization protocols.

What types of neurosurgical procedures are these retractors primarily intended for?

While the device description specifies they are self-retaining retractors for neurosurgical procedures, the exact clinical indications are not detailed beyond facilitating precise exposure and retraction of brain tissue during cranial surgeries. The advisory committee classification (Neurology) and product code (GZT) suggest their use in neurosurgical contexts, but the specific procedures are not listed.

How many different models or sizes are available in this product line?

The product line includes multiple model references, though the exact number or specific sizes are not detailed in the provided data. The OpenFDA listing references over 100 unique FEI numbers (e.g., 1000140363, 3003322138), indicating a variety of variants tailored for different neurosurgical applications. For precise sizing, refer to the manufacturer’s catalog or technical documentation.

What regulatory pathways have these devices undergone, and how does that affect their use?

The devices are authorized through FDA 510(k) clearance (K150378) under the Traditional Review pathway, classified as Class II, and comply with the Medical Device Regulation (MDR). This means they have undergone premarket review to demonstrate substantial equivalence to a predicate device, ensuring safety and performance. Their regulatory status does not imply clinical indications but confirms compliance for commercial distribution in the U.S. and EU markets.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
NICO Corporation

Sources (2)

  • FDA 510(k) K150378 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 19, 2026