Checkpoint Head & Neck Stimulator
510(k) K150005
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK150005 | Date19 Feb 2015 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Full name
- Checkpoint, Checkpoint Head & Neck
- 510(k) Number
- FDA Product Code
- ETN
- Device Class
- Class II
- Regulation
- 21 CFR Part 874.1820
- Advisory Committee
- Ear, Nose, Throat
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 20 Sep 2026
The Checkpoint Head & Neck Stimulator is a nerve stimulator designed for use in ear, nose, and throat procedures. It delivers electrical stimulation to identify and locate specific nerves, aiding in precise surgical navigation and anatomical preservation during head and neck interventions.
This device is supplied as a reusable medical instrument, featuring stainless steel (304) and medical-grade polyolefin tubing in direct contact with tissue, with a housing made of medical-grade ABS plastic. It is intended for use in controlled clinical settings, adhering to regulatory standards outlined under FDA 510(k) clearance (K150005) and classification ETN. No MRI safety or sterility specifications are noted in the available data.
Other devices from Ndi Medical, LLC
Questions
AI-generated answers, 20 Sep 2026
What types of surgical procedures is the Checkpoint Head & Neck Stimulator primarily used for, and how does it assist during these procedures?
The Checkpoint Head & Neck Stimulator is designed specifically for ear, nose, and throat (ENT) procedures. It delivers controlled electrical stimulation to help surgeons identify and locate critical nerves during head and neck surgeries, enabling precise anatomical navigation and reducing the risk of unintended nerve damage.
Is the Checkpoint Head & Neck Stimulator intended for single-use or reusable applications, and what materials are used in its construction?
The device is supplied as a reusable medical instrument. It features stainless steel (304) and medical-grade polyolefin tubing that come into direct contact with tissue, while the housing is made of medical-grade ABS plastic. This construction allows for repeated use in controlled clinical settings.
How is the regulatory status of the Checkpoint Head & Neck Stimulator determined, and what does this mean for its use in clinical settings?
The device holds an FDA 510(k) clearance (K150005) under classification ETN, determined as substantially equivalent to a predicate device. This clearance indicates it meets regulatory standards for safety and effectiveness as intended for use in controlled clinical settings, particularly for nerve stimulation in ENT procedures.
Are there any specific storage requirements or considerations for the Checkpoint Head & Neck Stimulator, particularly given its reusable nature?
The data does not specify sterility or MRI safety requirements, but since the device is reusable and made of materials like stainless steel and medical-grade plastics, proper cleaning, disinfection, and maintenance protocols must be followed to ensure safe reuse in clinical settings. Always adhere to manufacturer guidelines for storage and handling.
What should clinicians know about the regulatory route and classification of the Checkpoint Head & Neck Stimulator before incorporating it into their practice?
The device was reviewed by the FDA’s Ear, Nose, and Throat (EN) Advisory Committee and classified under product code ETN, with a special clearance type. This classification and route indicate it was evaluated for its intended use in nerve stimulation during ENT surgeries, ensuring compliance with regulatory standards for safety and performance in controlled clinical environments.