# K982960: Meical Device Technologies, Inc. Tru-Core Disposable Automatic Biopsy Instrument

- Pathway: 510(k) (Traditional)
- Applicant: Medical Device Technologies, Inc.
- Decided: Sep 23, 1998 after 30 days
- Product code: KNW (Instrument, Biopsy)
- Device class: 2
- Regulation: 21 CFR 876.1075
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K871390 (1987). 4 ancestors in all.
24 later devices descend from it; 3 cite 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)
- K962969: Medical Device Technologies, Inc.Ultra, Medical Device Technologies, Inc. (1996) Summary page 1.
- K982085: Medical Device Technologies, Inc. Tru-Core Disposale Semi-Automatic Biopdy Instrument, Medical Device Technologies, Inc. (1998) Summary page 1.

## Most influential descendants
- 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
- K150563: Marrow Cellution Bone Marrow Aspiration Needle (2015), 4 descendants of its own

## Recalls of this device
- Jul 2, 2024 · Class II · Z-3192-2024: Holes have been identified in biopsy instrument packaging trays compromising the sterile barrier, which may lead to cross contamination, or the introduction of micro-organisms into the access site, wh
- Jul 2, 2010 · Not classified · Z-0025-2011: Medical Device Technologies, Inc., dba Angiotech, Gaineville, Florida is recalling Tru-Core II Disposable Biopsy Devices due to compromised packaging integrity. The Tru-Core Disposable Automatic Biops

## Indications for use
The Tru-Core™ Disposable 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/K982960
Methodology: https://510kreport.com/methodology