# K013417: Misonix Irrigation System Moedl BC20P

- Pathway: 510(k) (Traditional)
- Applicant: Misonix, Inc.
- Decided: Jan 10, 2002 after 87 days
- Product code: GBX (Catheter, Irrigation)
- Device class: 1
- Regulation: 21 CFR 878.4200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K974233 (1998). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K974233: Lysonix Irrigation System, Lysonix, Inc. (1998) Summary page 1.

## Indications for use
The Misonix Irrigation System Model BC20P is indicated for use in the delivery of fluids in the following surgical specialties: General Surgical Procedures The Misonix Irrigation System (BC20P) is not intended for the administration of parenteral fluids, infusion of drugs or for any life sustaining purposes.

Source page: https://510kreport.com/device/K013417
Methodology: https://510kreport.com/methodology