# K981527: Mentor Pathway Introducer/Dilator

- Pathway: 510(k) (Traditional)
- Applicant: Mentor Corp.
- Decided: Jul 9, 1998 after 72 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
Longest line of descent: 1 generation back to K933458 (1994). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K963760: Non-Shielded Surgical Trocar and Sleeve, Ethicon Endo-Surgery, Inc. (1997) Summary page 5.
- K933458: Surgical Trocars, Ximed Medical Systems (1994) Summary page 5.
- K960232: Endoscopic Access Device, Applied Medical Technologies (1996) Summary page 5.
- K980763: Lysonix Lipoplasty Access Port, Lysonix, Inc. (1998). Cleared while this submission was under review Summary page 5.

## Indications for use
The Mentor Pathway Introducer is indicated for use as an operating port at the skin insertion site when instruments are utilized beneath the dermal layer for lipoplasty surgery applications. The Dilator is indicated for dilating the dermal layer and aiding in the insertion of the Pathway Introducer. The Plug is indicated for sealing the lumen of the Pathway Introducer when not in use.

Source page: https://510kreport.com/device/K981527
Methodology: https://510kreport.com/methodology