# K011997: Modular Valve Handles for Adaptable Tubes, Model 1298-XX-XX, 1295-XX-XX

- Pathway: 510(k) (Traditional)
- Applicant: Pajunk GmbH
- Decided: Jul 10, 2001 after 13 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.
3 later devices descend from it; 1 cites it directly.
0 of 4 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
- K062047: Adaptable Monopolar Adaptable and/or Retractable Electrodes (2006), 2 descendants of its own
- K190168: Aquas Probes (2019), 0 descendants of its own
- K073498: Laparoscopic and Electrosurgical Instruments and Accessories, Laparoscopy Rudolf System (2008), 0 descendants of its own

## Indications for use
suction/irrigation Systems for irrigation and aspiration of rinsing liquid in the operating area.

Source page: https://510kreport.com/device/K011997
Methodology: https://510kreport.com/methodology