# K080654: Pajunk's Kit for Balloon Aided Laparoscopy

- Pathway: 510(k) (Traditional)
- Applicant: PAJUNK GmbH Medizintechnologie
- Decided: May 8, 2008 after 62 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: 2 generations back to K012771 (2001). 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)
- K012771: Trocar Sleeve and Accessories, Models 1287-XX-XX, Pajunk GmbH (2001) Summary page 1.
- K063528: Trocasys, PAJUNK GmbH Medizintechnologie (2007) Summary page 1.

## Indications for use
PAJUNK®'s Kit for balloon aided laparoscopy is intended for making incisions into the patients body to allow insertion of endoscopes and endoscopic accessories during general and minimal invasive surgical procedures.

Source page: https://510kreport.com/device/K080654
Methodology: https://510kreport.com/methodology