# K142477: Intact Advance and Intact Excision XL, Intact BLES

- Pathway: 510(k) (Traditional)
- Applicant: Intact Medical Corporation
- Decided: Dec 15, 2014 after 103 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: 3 generations back to K003297 (2001). 3 ancestors in all.
2 later devices descend 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)
- K060413: Intact Breast Lesion Excision System and Advance, Intact Medical Corporation (2006) Summary page 4.
- K081057: Intact Breast Lesion Excision System with Intact Excision XL, Intact Medical Corporation (2008) Summary page 4.

## Most influential descendants
- 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® BLES with Intact® Excision XL wand and handle is indicated to provide tissue samples for diagnostic sampling of breast abnormalities The Intact® BLES with Intact® Excision XL wand and handle is intended to provide breast tissue for histologic examination with partial or complete removal of an imaged abnormality The Intact® BLES with Intact® Excision XL wand and handle is intended to provide breast tissue for histologic examination with partial removal of a palpable abnormality The Intact® BLES with Intact® Excision XL wand and handle is intended to preserve lesion architecture in samples with a diameter of 12–30mm 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 with Intact® Excision XL wand and handle 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/K142477
Methodology: https://510kreport.com/methodology