# K973818: T-Rex Biopsy Forceps

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Corp
- Decided: Dec 16, 1997 after 70 days
- Product code: DWZ (Device, Biopsy, Endomyocardial)
- Device class: 2
- Regulation: 21 CFR 870.4075
- 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 K870186 (1987). 1 ancestor in all.
2 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K870186: Endomyocardial Biopsy Device, Mansfield Scientific, Inc. (1987) Summary page 2.

## Most influential descendants
- K170726: Biopsy Forceps (2017), 1 descendant of its own
- K252722: Biopsy Forceps (2025), 0 descendants of its own

## Indications for use
The T*REX™ biopsy forceps are intended to obtain endomyocardial biopsy specimens. The specimens are taken for diagnosis of diseased heart tissue or for identification and monitoring of rejection factors in a transplanted heart.

Source page: https://510kreport.com/device/K973818
Methodology: https://510kreport.com/methodology