# K993361: Tubing Extension Set

- Pathway: 510(k) (Traditional)
- Applicant: Hurricane Medical
- Decided: Jan 4, 2000 after 90 days
- Product code: MSR (Tubing, Replacement, Phacofragmentation Unit)
- Device class: 2
- Regulation: 21 CFR 886.4150
- 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 no predicate by number.

## Indications for use
This device is used by an ophthalmic surgeon to extend the irrigation/aspiration syringe by use of the tubing extension set away from the cannula allowing better control of irrigation/aspiration during the ophthalmic surgical procedure. This also allows the surgeons assistant to perform the irrigation/aspiration process if needed.

Source page: https://510kreport.com/device/K993361
Methodology: https://510kreport.com/methodology