Brainlab Sterotatic Headring
by Brainlab Med. Computersysteme GmbH 510(k)
Active
510(k) K952390
Overview
The Brainlab Stereotactic Headring is a stereotaxic instrument (per FDA classification § 882.4560) designed as a rigid frame with a calibrated guide mechanism. It enables precise positioning of probes or surgical instruments within the brain or nervous system, facilitating minimally invasive procedures. This device is used in conjunction with stereotactic techniques to ensure accurate targeting during neurosurgical interventions. Its construction ensures stability and repeatability, critical for procedures requiring high precision.
The Brainlab Stereotactic Headring is supplied as a reusable device and is intended for use in sterile operating room environments. It is classified under product code HAW and holds an FDA 510(k) clearance (K952390) with a decision date of February 2, 1996. The device is manufactured by Brainlab Med. Computersysteme GmbH, based in Poing/Munchen, Germany. No additional regulatory markings or sterility assurances are specified beyond its classification and clearance status.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK952390 | Date2 Feb 1996 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- HAW
- Device Class
- Class II
- Regulation
- 21 CFR Part 882.4560
- Advisory Committee
- Neurology
- FDA Decision
- SESE Substantially Equivalent
Other devices from Brainlab Med. Computersysteme GmbH
Questions
What is the Brainlab Stereotactic Headring used for?
The Brainlab Stereotactic Headring is designed for neurosurgical procedures requiring precise targeting within the brain or nervous system. It serves as a rigid frame with a calibrated guide mechanism to ensure accurate positioning of surgical instruments or probes during minimally invasive stereotactic interventions. This stability and repeatability are critical for procedures where precision is essential, such as biopsies or deep brain stimulation.
Is the Brainlab Stereotactic Headring reusable or single-use?
The Brainlab Stereotactic Headring is supplied as a reusable device. It is intended for use in sterile operating room environments, where it can be cleaned, sterilized, and reused for subsequent procedures. Reusability is common for high-precision surgical instruments to maintain cost-effectiveness and reliability.
What regulatory approval does the Brainlab Stereotactic Headring hold?
The Brainlab Stereotactic Headring holds an FDA 510(k) clearance under the product code HAW, with the clearance number K952390. This classification confirms it is substantially equivalent to a legally marketed device and was reviewed by the Neurology Advisory Committee. The decision date for clearance was February 2, 1996.
How is the Brainlab Stereotactic Headring supplied and prepared for use?
The device is supplied as a reusable instrument, meaning it must be thoroughly cleaned, inspected, and sterilized before each use in a sterile operating room environment. Proper preparation ensures reliability and reduces the risk of contamination during neurosurgical procedures. Brainlab provides guidelines for maintenance to support its long-term usability.
What distinguishes the Brainlab Stereotactic Headring from other stereotactic frames?
The Brainlab Stereotactic Headring is distinguished by its rigid frame design and calibrated guide mechanism, which ensures high precision and repeatability during neurosurgical procedures. Unlike some alternatives, it is explicitly designed for stereotactic techniques, enabling accurate targeting of instruments or probes within the brain or nervous system. Its FDA clearance and long-standing use further validate its reliability in clinical settings.