# K003190: EN Bloc Biopsy System

- Pathway: 510(k) (Traditional)
- Applicant: Neothermia Corp.
- Decided: Jun 11, 2001 after 243 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: 11 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
9 later devices descend from it; 4 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K020047: Rubicor Breast Biopsy Device (2002), 5 descendants of its own
- K023601: Rubicor Encapsule Breast Biopsy Device, Model 30086 (2002), 4 descendants of its own
- K030049: Modification to Rubicor Encapsule Breast Biopsy Device, Model 30086 (2003), 3 descendants of its own
- K052506: Rubicor Encapsule Breast Biopsy Device, Model 31108 (2005), 1 descendant of its own
- K020031: EN-Bloc Biopsy System, Models 777-110, 777-120, 770-001, 777002, 777-006, 777-301, 777-302 (2002), 1 descendant of its own

## Recalls of this device
- Dec 28, 2016 · Class II · Z-1132-2017: Product sterility compromised due to breach of sterile barrier
- Dec 28, 2016 · Class II · Z-1130-2017: Product sterility compromised due to breach of sterile barrier
- Dec 28, 2016 · Class II · Z-1134-2017: Product sterility compromised due to breach of sterile barrier
- Dec 28, 2016 · Class II · Z-1126-2017: Product sterility compromised due to breach of sterile barrier
- Dec 28, 2016 · Class II · Z-1133-2017: Product sterility compromised due to breach of sterile barrier
- Dec 28, 2016 · Class II · Z-1129-2017: Product sterility compromised due to breach of sterile barrier
- Dec 28, 2016 · Class II · Z-1136-2017: Product sterility compromised due to breach of sterile barrier
- Dec 28, 2016 · Class II · Z-1127-2017: Product sterility compromised due to breach of sterile barrier
- Dec 28, 2016 · Class II · Z-1131-2017: Product sterility compromised due to breach of sterile barrier
- Dec 28, 2016 · Class II · Z-1135-2017: Product sterility compromised due to breach of sterile barrier
- Dec 28, 2016 · Class II · Z-1128-2017: Product sterility compromised due to breach of sterile barrier

Source page: https://510kreport.com/device/K003190
Methodology: https://510kreport.com/methodology