Sabre Auditory Evoked Response Stimulator
by Sle Limited
510(k) K993177
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK993177 | Date16 Nov 1999 | 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- Withdrawn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
- Sabre
- 510(k) Number
- FDA Product Code
- GWJ
- Device Class
- Class II
- Regulation
- 21 CFR Part 882.1900
- Advisory Committee
- Neurology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 20 Sep 2026
The Sabre is an Auditory Evoked Response Stimulator, a Class II medical device designed to elicit and measure auditory brainstem responses. It delivers controlled auditory stimuli to assess neural function in the auditory pathway, aiding in the evaluation of hearing disorders, cochlear implants, and neurological conditions such as auditory neuropathy.
The device is supplied as a reusable, non-sterile instrument intended for clinical use in neurology settings. It operates under FDA 510(k) clearance (K993177) and adheres to regulation 882.1900. No MRI safety classification or single-use designation is specified. Storage and handling follow standard electrical medical device protocols, with no additional sterility requirements stated.
Other devices from Sle Limited
Questions
AI-generated answers, 20 Sep 2026
What clinical specialties primarily use the Sabre device, and how does it support their evaluations?
The Sabre is designed for use in neurology settings, where it aids in assessing auditory brainstem responses. Clinicians in this field rely on it to evaluate hearing disorders, cochlear implant function, and neurological conditions like auditory neuropathy by delivering controlled auditory stimuli and measuring neural responses along the auditory pathway.
Is the Sabre device intended for single-use or repeated use in clinical environments, and what are the storage requirements?
The Sabre is a reusable, non-sterile instrument, meaning it is meant for multiple uses in clinical settings. Since it is not sterile, standard electrical medical device protocols should be followed for storage and handling, ensuring proper maintenance and cleaning between uses.
What regulatory pathway was followed for the FDA clearance of the Sabre, and what does this mean for its use?
The Sabre received FDA clearance through a 510(k) submission (K993177) under the Traditional review pathway, determined to be Substantially Equivalent to a predicate device. This clearance confirms its compliance with FDA regulations (e.g., 21 CFR 882.1900) and allows its use in clinical settings as an Auditory Evoked Response Stimulator for neurology evaluations.
Are there any specific safety considerations for using the Sabre device, particularly regarding MRI compatibility?
The Sabre does not have an explicitly stated MRI safety classification in its documentation, meaning its compatibility with MRI environments is not confirmed. Clinicians should verify compatibility with their MRI facility’s policies before use to avoid potential risks.
How many different models or configurations of the Sabre device are available, and what distinguishes them?
The Sabre is associated with multiple FEI numbers (e.g., 3002807739, 3011184129, etc.), which may indicate variations in software versions, firmware updates, or accessory configurations. While the exact differences between these models are not detailed in the provided data, these identifiers suggest updates or regional adaptations over time. For precise model specifications, refer to the manufacturer’s documentation or support.