# K021577: Modification to EN-Bloc Biopsy System

- Pathway: 510(k) (Special)
- Applicant: Neothermia Corp.
- Decided: May 29, 2002 after 15 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Neothermia’s 10mm en-bloc probe: named in the summary without a submission number
- (no number) Neothermia’s 20mm en-bloc probe: named in the summary without a submission number

## 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/K021577
Methodology: https://510kreport.com/methodology