Cryomedics Neurostat
510(k) K831963
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK831963 | Date12 Aug 1983 | 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- Withdrawn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
- 510(k) Number
- FDA Product Code
- GXH
- FDA applicant
- Spembly Medical , Ltd.
- Device Class
- Class II
- Regulation
- 21 CFR Part 882.4250
- Advisory Committee
- Neurology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Cryomedics Neurostat is a Surgical Cryogenic Device designed for neurosurgical applications, specifically for controlled cryogenic ablation of neural tissue. It operates by delivering precise cryogenic temperatures to target areas, enabling localized tissue freezing for therapeutic interventions in neurology. This device is classified under product code GXH and falls within the Class II regulatory category, as defined by the FDA.
The Neurostat is intended for use in sterile operating room environments and is supplied as a reusable medical instrument. It is regulated under the FDA 510(k) clearance (K831963) and follows the Traditional 510(k) pathway, with a decision date of August 12, 1983. The device is intended for neurosurgical procedures and adheres to cryogenic safety standards as outlined in regulation number 882.4250. No additional sterility or single-use specifications are noted in the regulatory data.
Other devices from Spembly Medical, Ltd.
Questions
AI-generated answers, 1 Oct 2026
What is the Cryomedics Neurostat used for in neurosurgery?
The Cryomedics Neurostat is a surgical cryogenic device designed specifically for controlled cryogenic ablation of neural tissue. It delivers precise cryogenic temperatures to target areas during neurosurgical procedures, allowing for localized freezing of tissue as part of therapeutic interventions in neurology. This targeted approach helps minimize damage to surrounding healthy tissue while achieving the desired clinical outcome.
Is the Neurostat a single-use or reusable device?
The Neurostat is supplied as a reusable medical instrument. It is intended for use in sterile operating room environments, where it undergoes proper cleaning, sterilization, and maintenance between procedures to ensure safety and efficacy. Reusability is common for high-precision surgical tools like this, provided rigorous protocols are followed.
What regulatory pathway does the Neurostat follow?
The Cryomedics Neurostat is regulated under the FDA’s Traditional 510(k) pathway, with clearance granted under 510(k) number K831963. It was determined to be substantially equivalent to a legally marketed predicate device and falls under product code GXH, classified as a Class II device. This pathway ensures compliance with cryogenic safety standards outlined in regulation number 882.4250.
How is the Neurostat sterilized for use in the operating room?
While the regulatory data does not specify a particular sterility method, the Neurostat is intended for use in sterile operating room environments. Reusable devices like this typically undergo sterilization via autoclaving, ethylene oxide, or other validated methods to ensure it remains free of pathogens before each procedure. The manufacturer’s instructions for use would detail the recommended sterilization protocol.
What advisory committee reviewed the Neurostat’s clearance?
The Neurostat’s FDA clearance was reviewed by the Neurology (NE) Advisory Committee. This committee provides expert input on the safety and effectiveness of devices intended for neurosurgical and neurological applications, ensuring that submissions like the Neurostat meet rigorous standards for controlled cryogenic ablation in clinical practice.