# K063233: Deltacut (Apparatus and Cannula)

- Pathway: 510(k) (Traditional)
- Applicant: PAJUNK GmbH Medizintechnologie
- Decided: Apr 30, 2007 after 187 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K88349: Bard Aspiration Biopsy System ("Magnum"). Number could not be read Summary page 1.

## Indications for use
The PAJUNK DeltaGut biopsy system consists of a gun and a disposable cannula. It is intended for sbtaining bitisles fron soft tissues and soft tissue tumors. It is not appropriate for bone biopsies. The PajunkfeltkCiut'blopsy cannulas are single use sterile devices. They are intended for obtaining biopsies from soft tissues and soft tissue tumors. They areonly t be used in combinetfon with the Deltacut biopsy gun, but they are available sepeteate It i[ ot appmropate for bone biopsies.

Source page: https://510kreport.com/device/K063233
Methodology: https://510kreport.com/methodology