Universal Cannula System
510(k) K863590
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK863590 | Date23 Oct 1986 | 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- Withdrawn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
- HRX
- Device Class
- Class II
- Regulation
- 21 CFR Part 888.1100
- Advisory Committee
- Orthopedic
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 20 Sep 2026
The Universal Cannula System is a surgical device classified under the product code HRX, designed for orthopedic applications. It consists of cannulas used to guide instruments or implants during procedures, ensuring precision and access in bone or joint surgeries. The system is intended to facilitate minimally invasive techniques by providing a pathway for surgical tools.
This device is supplied as a reusable medical instrument, as indicated by its FDA 510(k) clearance under the Traditional pathway. It was granted Substantially Equivalent status by the Orthopedic Advisory Committee in 1986 (K863590). No specific sterility or MRI safety details are provided in the available data, though standard surgical sterilization practices would apply in clinical use. The system is regulated under the FDA’s 510(k) premarket notification process.