# K020031: EN-Bloc Biopsy System, Models 777-110, 777-120, 770-001, 777002, 777-006, 777-301, 777-302

- Pathway: 510(k) (Traditional)
- Applicant: Neothermia Corp.
- Decided: Mar 27, 2002 after 82 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: none
- 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.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003190: EN Bloc Biopsy System, Neothermia Corp. (2001) Summary page 1.
- K983296: Auto Suture Abbi System, United States Surgical, A Division of Tyco Healthc (1999) Summary page 1.

## Most influential descendants
- K052246: Modification to EN-Bloc Biopsy System (2005), 0 descendants of its own

## Indications for use
The en-bloc Biopsy System is intended for diagnostic sampling of breast tissue during a breast biopsy procedure.

Source page: https://510kreport.com/device/K020031
Methodology: https://510kreport.com/methodology