# K980763: Lysonix Lipoplasty Access Port

- Pathway: 510(k) (Traditional)
- Applicant: Lysonix, Inc.
- Decided: May 28, 1998 after 90 days
- Product code: QPB (System, Suction, Lipoplasty For Removal)
- Device class: 2
- Regulation: 21 CFR 878.5040
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices 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) Applied Medical Technologies Endoscopic Access Device: named in the summary without a submission number

## Most influential descendants
- K981527: Mentor Pathway Introducer/Dilator (1998), 0 descendants of its own

## Indications for use
The LySonix Lipoplasty Access Port is indicated for use as an access portal to the surgical site and to reduce trauma to the incision site caused by removal and re-entry of cannulas during lipoplasty procedures.

Source page: https://510kreport.com/device/K980763
Methodology: https://510kreport.com/methodology