# K060413: Intact Breast Lesion Excision System and Advance

- Pathway: 510(k) (Traditional)
- Applicant: Intact Medical Corporation
- Decided: Apr 27, 2006 after 70 days
- Product code: KNW (Instrument, Biopsy)
- Device class: 2
- Regulation: 21 CFR 876.1075
- 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 K003297 (2001). 1 ancestor in all.
4 later devices descend from it; 2 cite 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)
- K003297: Mammotome Hand Held Probe, Model MHH8, Ethicon Endo-Surgery, Inc. (2001) Summary page 1.

## Cited in the summary but kept off the family tree
- K003190: EN Bloc Biopsy System, Neothermia Corp. (2001). Our reading of the summary gave K003190, FDA’s number for EN Bloc Biopsy System (Neothermia Corp.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Intact Medical Corporation's intact Tm BLES”. Kept off the family tree. Summary page 1.
- K021577: Modification to EN-Bloc Biopsy System, Neothermia Corp. (2002). Our reading of the summary gave K021577, FDA’s number for Modification to EN-Bloc Biopsy System (Neothermia Corp.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Intact Medical Corporation's intact Tm BLES”. Kept off the family tree. 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). Our reading of the summary gave K020031, FDA’s number for EN-Bloc Biopsy System, Models 777-110, 777-120, 770-001… (Neothermia Corp.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Intact Medical Corporation's intact Tm BLES”. Kept off the family tree. 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). Our reading of the summary gave K042170, FDA’s number for EN-Bloc Biopsy System… (Neothermia Corporation). Its FDA name has none of the distinctive words the summary uses for the device it names, “Intact Medical Corporation's intact Tm BLES”. Kept off the family tree. Summary page 1.
- K050737: Neothermia EN-Bloc Biopsy System, Neothermia Corporation (2005). Our reading of the summary gave K050737, FDA’s number for Neothermia EN-Bloc Biopsy System (Neothermia Corporation). Its FDA name has none of the distinctive words the summary uses for the device it names, “Intact Medical Corporation's intact Tm BLES”. Kept off the family tree. Summary page 1.
- K052246: Modification to EN-Bloc Biopsy System, Neothermia Corporation (2005). Our reading of the summary gave K052246, FDA’s number for Modification to EN-Bloc Biopsy System (Neothermia Corporation). Its FDA name has none of the distinctive words the summary uses for the device it names, “Intact Medical Corporation's intact Tm BLES”. Kept off the family tree. Summary page 1.

## Most influential descendants
- K081057: Intact Breast Lesion Excision System with Intact Excision XL (2008), 3 descendants of its own
- K142477: Intact Advance and Intact Excision XL, Intact BLES (2014), 2 descendants of its own
- K152596: Intact® Gen2 System (2016), 1 descendant of its own
- K252183: Resitu Slider 09 (RESL09) (2025), 0 descendants of its own

## Indications for use
The intact TM BLES is indicated to provide tissue samples for diagnostic sampling of breast abnormalities. The intactTM BLES is intended to provide breast tissue for histologic examination with partial or complete removal of an imaged abnormality. The intactTM BLES 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 intact BLES 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/K060413
Methodology: https://510kreport.com/methodology