# K052246: Modification to EN-Bloc Biopsy System

- Pathway: 510(k) (Traditional)
- Applicant: Neothermia Corporation
- Decided: Aug 22, 2005 after 5 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: 4 generations back to K871390 (1987). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 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.
- K021577: Modification to EN-Bloc Biopsy System, Neothermia Corp. (2002) Summary page 1.
- K020031: EN-Bloc Biopsy System, Models 777-110, 777-120, 770-001, 777002, 777-006, 777-301, 777-302, Neothermia Corp. (2002) Summary page 1.
- K042170: EN-Bloc Biopsy System Model#777-110,777-001,777-002,777-006,777-301,777-302,777-115,777-120, Neothermia Corporation (2004) Summary page 1.
- K050737: Neothermia EN-Bloc Biopsy System, Neothermia Corporation (2005) Summary page 1.
- K030472: Mammotome Biopsy System Probe & Housing, Mammotome Hand-Held System, Ethicon Endo-Surgery, Inc. (2003) Summary page 1.

## Indications for use
The en-bloc Biopsy System is indicated to provide tissue samples for diagnostic sampling of breast abnormalities. The en-bloc Biopsy System is intended to provide breast tissue for histologic examination with partial or complete removal of an imaged abnormality. The en-bloc Biopsy System is intended to provide breast tissue for histologic examination with partial removal of a palpable abnormality. The extent of a histologic abnormality cannot always be readily determined from palpation or imaged appearance. Therefore, the extent of removal of the palpable or imaged evidence of an abnormality does not predict the extent of removal of a histologic abnormality, e.g., malignancy. When the sampled abnormality is not histologically benign, it is essential that the tissue margins be examined for completeness of removal using standard surgical procedures. In instances when a patient presents with a palpable abnormality that has been classified as benign through clinical and/or radiological criteria (e.g., fibroadenoma, fibrocystic lesion), the en-bloc Biopsy System may also be used to partially remove such palpable lesions. Whenever breast tissue is removed, histologic evaluation of the tissue is the standard of care. When the sampled abnormality is not histologically benign, it is essential that the tissue margins be examined for completeness of removal using standard surgical procedures.

Source page: https://510kreport.com/device/K052246
Methodology: https://510kreport.com/methodology