# K152596: Intact® Gen2 System

- Pathway: 510(k) (Traditional)
- Applicant: Intact Medical Corporation
- Decided: Feb 15, 2016 after 158 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: 4 generations back to K003297 (2001). 4 ancestors in all.
1 later device descends 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)
- K142477: Intact Advance and Intact Excision XL, Intact BLES, Intact Medical Corporation (2014) Summary page 4.

## Most influential descendants
- K252183: Resitu Slider 09 (RESL09) (2025), 0 descendants of its own

## Indications for use
• The Intact® Gen2 System is indicated to provide tissue samples for diagnostic sampling of breast abnormalities. • The Intact® Gen2 System is intended to provide breast tissue for histologic examination with partial or complete removal of an imaged abnormality. • The Intact® Gen2 System is intended to provide breast tissue for histologic examination with partial removal of a palpable abnormality. • The Intact® Gen2 System is intended to preserve lesion architecture in samples with a diameter of 12–30 mm. 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® Gen2 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/K152596
Methodology: https://510kreport.com/methodology