Endoscopic Spinal Access System
by Endius, Inc.
510(k) K994425
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK994425 | Date16 Feb 2000 | 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- Withdrawn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
- Modification to Endoscopic Spinal Access System
- 510(k) Number
- FDA Product Code
- HRX
- Device Class
- Class II
- Regulation
- 21 CFR Part 888.1100
- Advisory Committee
- Orthopedic
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Endoscopic Spinal Access System is a surgical device classified as a spinal access system, designed for posterior endoscopic procedures. It provides controlled access to the lumbar spine, facilitating minimally invasive interventions such as discectomy, nucleotomy, and non-instrumented posterolateral fusion. This system is engineered to enhance precision and reduce trauma during spinal surgeries by enabling direct visualization and manipulation of spinal structures.
This device is intended for single-use in operating room settings and has received FDA clearance under a 510(k) submission (K994425). It is supplied sterile and must be handled according to standard surgical protocols. The system is not MRI-compatible and requires proper storage in a clean, dry environment to maintain sterility and functionality. No additional regulatory approvals beyond the stated 510(k) clearance are implied.
Other devices from Endius, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the Endoscopic Spinal Access System designed for?
This system is engineered for posterior endoscopic spinal surgeries, specifically to provide controlled access to the lumbar spine. It facilitates minimally invasive procedures like discectomy (removal of herniated disc material), nucleotomy (removal of nucleus pulposus), and non-instrumented posterolateral fusion (spinal stabilization without hardware). The design enables direct visualization and manipulation of spinal structures, reducing trauma compared to traditional open surgery.
How is the Endoscopic Spinal Access System supplied and prepared for use?
The system is supplied sterile and intended for single-use in operating room settings only. It must be handled according to standard surgical protocols to maintain sterility. Since it is not reusable, each sterile package should be opened only once and used immediately for a single procedure.
Can this device be reused or is it strictly single-use?
The Endoscopic Spinal Access System is explicitly designed for single-use only. Reuse is not recommended or supported by the manufacturer, as it could compromise sterility, functionality, and patient safety. Each sterile package is intended for one surgical procedure to ensure compliance with medical device regulations and best practices.
What storage conditions are required to maintain the device’s sterility and performance?
The system must be stored in a clean, dry environment to preserve sterility and functionality. Avoid exposure to moisture, extreme temperatures, or contamination. The sterile barrier should remain intact until immediate preoperative use, and the device should not be stored for prolonged periods after opening the packaging.
Is the Endoscopic Spinal Access System compatible with MRI machines?
No, the Endoscopic Spinal Access System is explicitly not MRI-compatible. This means it should not be used in or near MRI environments, as metallic components or other materials could interfere with imaging or pose safety risks during the procedure. Always verify compatibility with imaging equipment before use.