Neuro Check Device
by Baxano, Inc.
510(k) K092729
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK092729 | Date2 Oct 2009 | 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- Withdrawn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
- Baxano Neuro Check Device
- 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, 1 Oct 2026
The Neuro Check Device is a nerve stimulator designed to localize motor nerves during surgical procedures. According to regulatory classification, it falls under the category of a nerve stimulator, aiding in identifying nerve pathways where direct visualization is challenging, particularly in otolaryngology and related specialties.
This device is intended for single-use and is supplied sterile. It is classified as a Class II medical device under FDA regulation 874.1820 and received a Special 510(k) clearance with a decision of Substantially Equivalent. The device is not indicated for MRI use and is distributed in various configurations, including those with IO-Flex wire. Storage and handling must comply with sterile medical device protocols.
Other devices from Baxano, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the Baxano Neuro Check Device used for?
The Baxano Neuro Check Device is a nerve stimulator designed to help surgeons identify and localize motor nerves during procedures where direct visualization is difficult. This is particularly useful in otolaryngology and related specialties, ensuring safer surgical navigation by confirming nerve pathways before incision or manipulation.
How is the Neuro Check Device supplied and what does this mean for clinical use?
The Neuro Check Device is supplied sterile and intended for single-use only. This means each device is pre-sterilized, ready for immediate clinical use, and should not be reused or reprocessed. Single-use devices reduce the risk of cross-contamination and ensure consistent performance, which is critical for nerve stimulation accuracy during surgery.
Are there different configurations or models available for the Neuro Check Device?
Yes, the Neuro Check Device is distributed in various configurations, including versions with IO-Flex wire. These configurations may offer flexibility in electrode placement or stimulation parameters, allowing clinicians to adapt the device to specific surgical needs. The exact model or reference number should be confirmed with the manufacturer or distributor to ensure compatibility with the intended procedure.
How should the Neuro Check Device be stored and handled?
Since the Neuro Check Device is sterile and single-use, it must be stored and handled according to sterile medical device protocols. This includes maintaining the device in its original packaging until use, storing it in a clean, dry environment protected from contamination, and following manufacturer guidelines for shelf life and expiration dates. Improper storage could compromise sterility and device integrity.
Can the Neuro Check Device be used in MRI environments?
No, the Neuro Check Device is explicitly not indicated for MRI use. This is important because MRI environments involve strong magnetic fields that can interfere with electronic medical devices, potentially causing malfunctions or safety risks. Always verify device compatibility with the specific clinical environment before use.