Bright Medical Dilation Retractor System
by Bright Medical Instruments 510(k)
Active
510(k) K992898
Overview
The Bright Medical Dilation Retractor System is a self-retracting device for neurosurgery that provides minimally invasive spinal access. The system includes a series of dilators, tubular retractors of various lengths, and a guide wire. The device is placed down to the lamina and attached to a flexible arm for self-locking access to the spinal site.
The system is used in operating rooms by neurosurgeons during discectomy procedures to provide a stable surgical corridor for microscopes and instruments. It is supplied as a single-use device and is not MRI safe. The device has FDA 510(k) clearance with product code GZT and is classified as a Class II device for neurology.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK992898 | Date21 Oct 1999 | 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- Withdrawn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
- Full name
- The Bright Medical Dilation Retractor System
- 510(k) Number
- FDA Product Code
- GZT
- Device Class
- Class II
- Regulation
- 21 CFR Part 882.4800
- Advisory Committee
- Neurology
- FDA Decision
- SESE Substantially Equivalent
Questions
What is the Bright Medical Dilation Retractor System used for?
The Bright Medical Dilation Retractor System is a self-retracting device used by neurosurgeons during discectomy procedures to provide minimally invasive spinal access. It creates a stable surgical corridor for microscopes and instruments.
What components are included in the Bright Medical Dilation Retractor System?
The system includes a series of dilators, tubular retractors of various lengths, and a guide wire. The device is placed down to the lamina and attached to a flexible arm for self-locking access to the spinal site.
Is the Bright Medical Dilation Retractor System reusable or MRI safe?
The device is supplied as a single-use device and is not MRI safe. It should be discarded after a single procedure to ensure patient safety and maintain device integrity.
What is the regulatory status of the Bright Medical Dilation Retractor System?
The device has FDA 510(k) clearance with product code GZT and is classified as a Class II device for neurology. It received clearance on October 21, 1999, under K number K992898.