# K252183: Resitu Slider 09 (RESL09)

- Pathway: 510(k) (Traditional)
- Applicant: Resitu Medical AB
- Decided: Sep 24, 2025 after 75 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: 5 generations back to K003297 (2001). 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)
- K152596: Intact® Gen2 System, Intact Medical Corporation (2016) Summary page 5.

## Indications for use
Resitu Slider 09 is intended to provide breast tissue for diagnostic analysis of imaged abnormalities.

Source page: https://510kreport.com/device/K252183
Methodology: https://510kreport.com/methodology