# K980849: Surgin Kit

- Pathway: 510(k) (Traditional)
- Applicant: Surgin Surgical Instrumentation, Inc.
- Decided: Jul 9, 1998 after 154 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
This product is indicated for use with the Alcon Series 20,000 Legacy Phacoemulsifier. It may be utilized in phaco procedures in which either combined or segregated automated irrigation and aspiration is deemed appropriate.

Source page: https://510kreport.com/device/K980849
Methodology: https://510kreport.com/methodology