# K053282: Adaptable Monopolar Electrodes with Ceramic Tip

- Pathway: 510(k) (Special)
- Applicant: Pajunk GmbH
- Decided: Dec 13, 2005 after 18 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- 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 K935270 (1994). 3 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033249: Pajunk Modular Handle Instruments, Pajunk GmbH (2004) Summary page 1.
- K970541: Aesculap Modular Monopolar Electrodes, Aesculap, Inc. (1997) Summary page 1.

## 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
Ceramic tip electrodes are used during minimal invasive surgery, according to the professional surgeon and the instructions for use. Ceramic tip electrodes are instruments insulated for optional monopolar coagulation which enable a surgeon to grasp, manipulate, dissect, retrieve, biopsy, cut or coagulate internal tissue or organs while performing laparoscopic procedures.

Source page: https://510kreport.com/device/K053282
Methodology: https://510kreport.com/methodology