# K063528: Trocasys

- Pathway: 510(k) (Traditional)
- Applicant: PAJUNK GmbH Medizintechnologie
- Decided: Jan 17, 2007 after 56 days
- Product code: GCJ (Laparoscope, General & Plastic Surgery)
- Device class: 2
- Regulation: 21 CFR 876.1500
- 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 K012771 (2001). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012771: Trocar Sleeve and Accessories, Models 1287-XX-XX, Pajunk GmbH (2001) Summary page 1.

## Most influential descendants
- K080654: Pajunk's Kit for Balloon Aided Laparoscopy (2008), 0 descendants of its own

## Indications for use
The Pajunk TrocaSys is a manually operated surgicall device intended for making incisions into the patient's body to allow the insertion of endoscopes and endoscopic accessories during general endoscopic and laparoscopic procedures.

Source page: https://510kreport.com/device/K063528
Methodology: https://510kreport.com/methodology