# K230646: SUREcore Prime Biopsy Instrument

- Pathway: 510(k) (Traditional)
- Applicant: Uro-1 Medical, Inc.
- Decided: Nov 29, 2023 after 266 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 K895897 (1989). 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)
- K980226: Manan Pro-Mag Automatic Biopsy System, Medical Device Technologies, Inc. (1998) Summary page 4.

## Indications for use
The UR0-1 SUREcore Prime Device is a reusable system for histological core biopsies. It is used to obtain tissue from transrectal or transperineal biopsy of the prostate. It has a throw (advancement) of 25 mm and is used in conjunction with a single use SUREcore biopsy needle.

Source page: https://510kreport.com/device/K230646
Methodology: https://510kreport.com/methodology