# K012771: Trocar Sleeve and Accessories, Models 1287-XX-XX

- Pathway: 510(k) (Traditional)
- Applicant: Pajunk GmbH
- Decided: Nov 14, 2001 after 89 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
No predicates in its family tree.
2 later devices descend from it; 2 cite 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)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K063528: Trocasys (2007), 1 descendant of its own
- K080654: Pajunk's Kit for Balloon Aided Laparoscopy (2008), 0 descendants of its own

## Indications for use
Manually operated surgical device intended for making incisions into the patient’s body to allow insertion of endoscopes and endoscopic accessories during general endoscopic and laparoscopic procedures Manually operated surgical device intended for making incisions into the patient’s body to allow insertion of endoscopes and endoscopic accessories during general endoscopic and laparoscopic procedures Manually operated surgical device intended for creating a surgical space by dissecting layers of connective tissue along natural planes to allow insertion of endoscopes and endoscopic accessories during general endoscopic and laparoscopic procedures Manually operated surgical device intended for providing a well anchored and tight instrument channel to allow insertion of endoscopes and endoscopic accessories during general endoscopic and laparoscopic procedures

Source page: https://510kreport.com/device/K012771
Methodology: https://510kreport.com/methodology