# K080674: Pajunk's Primocut Disposable Biopsy System

- Pathway: 510(k) (Traditional)
- Applicant: PAJUNK GmbH Medizintechnologie
- Decided: May 9, 2008 after 60 days
- Product code: MJG (Device, Percutaneous, Biopsy)
- Device class: 1
- Regulation: 21 CFR 878.4800
- 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 K950732 (1995). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052802: Manan Bio-Cut Soft Tissue Biopsy Needle, Manan Medical Products, Inc. (2005) Summary page 1.
- K024120: Modification to Temno Biopsy Needles, Allegiance Healthcare Corp. (2003) Summary page 1.

## Indications for use
PAJUNKI's PrimoCut Disposable Biopsy system is indicated for soft tissue biopsy.

Source page: https://510kreport.com/device/K080674
Methodology: https://510kreport.com/methodology