# K233294: Automatic Biopsy Needle BAM, Semi-Automatic Needle BIM

- Pathway: 510(k) (Traditional)
- Applicant: Itp Innovative Tomography Products GmbH
- Decided: Jun 18, 2024 after 263 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 K960064 (1996). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K222462: Semi-automatic Biopsy-Needle (BIM 18/20); Semi-automatic Biopsy-Needle (BIM 18.15); Semi-automatic Biopsy-Needle (BIM 18/10);Semi-automatic Biopsy-Needle (BIM 16/20);Semi-automatic Biopsy-Needle (BIM 16/15);Semi-automatic Biopsy-Needle (BIM 16/10);Semi-automatic Biopsy-Needle (BIM 14/20);Semi-automatic Biopsy-Needle (BIM 14/15);Semi-automatic Biopsy-Needle (BIM 14/10), Itp Innovative Tomography Products GmbH (2023) Summary page 4.

## Indications for use
The biopsy-needle is intended for soft-tissue biopsy (such as breast, kidney, liver, prostate).

Source page: https://510kreport.com/device/K233294
Methodology: https://510kreport.com/methodology