# K981156: Dyonics Intelijet Inflow/Outflow Cannula

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew, Inc.
- Decided: May 20, 1998 after 50 days
- Product code: HRX (Arthroscope)
- Device class: 2
- Regulation: 21 CFR 888.1100
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Dyonics InteliJET Reusable Cannulas: named in the summary without a submission number
- (no number) 3M Inflow/Outflow Pressure Sensing Scope Sheath System: named in the summary without a submission number

## Indications for use
The Dyonics® InteiJET™ Inflow/Outflow Cannula is indicated for use with the InteliJET Fluid Management System during arthroscopic surgical procedures of the knee, shoulder and small joints to regulate flow of irrigation fluids through the joint to maintain intra-articular pressure for uniform distention and clear visualization of the surgical site.

Source page: https://510kreport.com/device/K981156
Methodology: https://510kreport.com/methodology