# K113209: Chiba Sono

- Pathway: 510(k) (Traditional)
- Applicant: Pajunk GmbH
- Decided: Nov 21, 2011 after 21 days
- Product code: KNW (Instrument, Biopsy)
- Device class: 2
- Regulation: 21 CFR 876.1075
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K962977 (1997). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063697: Special Sprotte, Chiba, DR Steinhoff Kit, PAJUNK GmbH Medizintechnologie (2007) Summary page 1.

## Indications for use
PAJUNKos soft tissue biopsy, puncture and aspiration cannulas and needles are intended for obtaining biopsies from soft tissues, for use in puncturing and for aspiration. They are not appropriate for bone biopsies.

Source page: https://510kreport.com/device/K113209
Methodology: https://510kreport.com/methodology