# K982085: Medical Device Technologies, Inc. Tru-Core Disposale Semi-Automatic Biopdy Instrument

- Pathway: 510(k) (Traditional)
- Applicant: Medical Device Technologies, Inc.
- Decided: Jul 17, 1998 after 32 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 K871390 (1987). 3 ancestors in all.
25 later devices descend from it; 1 cites it directly.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K914874: Manan Pro-Mag Automatic Biopsy Device, Manan Medical Products, Inc. (1992) Summary page 1.
- K962969: Medical Device Technologies, Inc.Ultra, Medical Device Technologies, Inc. (1996) Summary page 1.

## Most influential descendants
- K982960: Meical Device Technologies, Inc. Tru-Core Disposable Automatic Biopsy Instrument (1998), 24 descendants of its own
- K990839: Tru-Core I Reusable Biopsy Instrument (1999), 20 descendants of its own
- K051506: Mielo-Can, Best-Lisas, Ben - Bone Biopsy.  Fast-Cut, Colt, Spring-Cut, Bio-Cut - Soft Tissue Biopsy (2005), 18 descendants of its own
- K131157: Ranfac Bone Marrow Aspiration Needle (2013), 12 descendants of its own
- K140991: Ranfac Aspiration Needle with Adjustable Guide (2014), 5 descendants of its own

## Indications for use
The Tru-Core™ Disposable Semi-Automatic Biopsy Instrument is intended for use in obtaining multiple core samples from soft tissue such as the liver, kidney, prostate, breast, and various soft tissue lesions. It is not intended for bone.

Source page: https://510kreport.com/device/K982085
Methodology: https://510kreport.com/methodology