# K242228: Triopsy Actuator (TMSDGB); Triopsy Biopsy Needle (BN-1825-36-01); Triopsy Biopsy Needle (BN-1825-55-01)

- Pathway: 510(k) (Traditional)
- Applicant: Triopsy Medical, Inc.
- Decided: Jan 10, 2025 after 164 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: 1 generation back to K934370 (1994). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K934370: Bip Biopsy Needle Modification, Bip USA, Inc. (1994) Summary page 5.
- K934371: Bip Multi Modification, Bip USA, Inc. (1994) Summary page 5.

## Indications for use
The Triopsy Biopsy System (instrument and needles) is intended for use in obtaining biopsies from the prostate.

Source page: https://510kreport.com/device/K242228
Methodology: https://510kreport.com/methodology