Stryker CrossFlow Integrated Arthroscopy Pump
510(k) K191259
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK191259 | Date12 Jul 2019 | StatusActive |
Official records
- FDA 510(k) database K191259
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- Withdrawn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, 23 Sep 2026
The Stryker CrossFlow Integrated Arthroscopy Pump is an arthroscopic pump designed to provide consistent visualization during surgical procedures. It features ReconiSense Technology, which determines optimal suction rates for cutters, burs, and RF probes to manage suction and decrease fluid usage.
This device is authorized via FDA 510K clearance under K191259. It is intended for use in orthopedic settings to support arthroscopic instrumentation.