# K063697: Special Sprotte, Chiba, DR Steinhoff Kit

- Pathway: 510(k) (Traditional)
- Applicant: PAJUNK GmbH Medizintechnologie
- Decided: Feb 14, 2007 after 63 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: 2 generations back to K962977 (1997). 2 ancestors in all.
1 later device descends 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)
- K980211: Mri Chiba,Spinal,Breast Localization,Automatic Cutting Needles, Manan Medical Products, Inc. (1998) Summary page 1.

## Most influential descendants
- K113209: Chiba Sono (2011), 0 descendants of its own

## Indications for use
Pajunks soft tissue biopsy, puncture and aspiration cannulas and needles listed above are intended for obtaining biopsies from soft tissues, for use in puncturing and for aspiration. They are not appropriate for bone biopsies. Pajunks soft tissue puncture and aspiration Kit acc. Steinhoff is intended for use in puncturing and aspiring for soft tissue biopsy. Pajunks breast localization cannulas/ needles can be used in Mammographic procedures to obtain breast lesion tissue. Pajunks Breast localization cannulas/ needles are intended for diagnostic sampling of breast tissue during breast biopsy procedures. They are to be used for diagnostic purposes only and are not intended for therapeutic uses, The Breast localization cannulas/ needles are indicated to provide breast tissue samples for diagnostic sampling of breast abnormalities. It is designed to provide breast tissue for histologic examination with partial or complete removal of the imaged abnormality. The extent of histologic abnormality cannot be reliably determined from its mammographic appearance. Therefore, the extent of removal of the imaged evidence of an abnormality does not predict the extent of removal of a histologic abnormality (e.g., malignancy). When the sampled abnormality is not histologically benign, it is essential that the tissue margins be examined for completeness of removal using standard surgical procedures. This device is not indicated fo' use under MR based imaging technologies, such as MRI.

Source page: https://510kreport.com/device/K063697
Methodology: https://510kreport.com/methodology