# K120130: Faller Trocar

- Pathway: 510(k) (Traditional)
- Applicant: Medigroup, Inc.
- Decided: May 21, 2012 after 125 days
- Product code: FJS (Catheter, Peritoneal, Long-Term Indwelling)
- Device class: 2
- Regulation: 21 CFR 876.5630
- 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 K823331 (1983). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K910786: Trocar (Faller Stylet), Accurate Surgical Instruments Co. (1991) Summary page 1.
- K823331: PC-204 Tunnelor, Medigroup (1983) Summary page 1.

## Indications for use
The Faller Trocar is used to create an ante-grade subcutaneous tunnel for a peritoneal dialysis catheter from the initial implantation site to the preferred exit-site. It separates the tissue as it leads the catheter through to the skin exit-site.

Source page: https://510kreport.com/device/K120130
Methodology: https://510kreport.com/methodology