# K983296: Auto Suture Abbi System

- Pathway: 510(k) (Traditional)
- Applicant: United States Surgical, A Division of Tyco Healthc
- Decided: Jun 4, 1999 after 256 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: 2 generations back to K871390 (1987). 2 ancestors in all.
5 later devices descend from it; 4 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K963825: Auto Suture* Abbi* System, United States Surgical, A Division of Tyco Healthc (1996). Our OCR of the scanned summary read K963325, FDA’s number for Synthes Titanium (TI) Alloy High Tibial Osteotomy (Hto)… (Synthes (Usa)). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Auto Suture ABBI System”.

## Most influential descendants
- K020031: EN-Bloc Biopsy System, Models 777-110, 777-120, 770-001, 777002, 777-006, 777-301, 777-302 (2002), 1 descendant of its own
- K011575: 22MM Siteselect Breast Biopsy Device Model SSD022 (2001), 1 descendant of its own
- K052246: Modification to EN-Bloc Biopsy System (2005), 0 descendants of its own
- K040087: Rabbit (2004), 0 descendants of its own
- K020024: Caris Minitome Biopsy Instrument (2002), 0 descendants of its own

## Indications for use
To be used when stereotactically localized, large diameter, breast biopsies, identified by the placement of a needle localization wire, are desired for diagnostic sampling of 2 mammographic abnormality that i is suspicious for malignant disease (i.c. usually BIRADS class 4 or 5). The ABBI* device is intended to provide breast tissue for histologic examination with partial or complete removal of the imaged abnormality. The extent of a histologic abnormality cannot be determined from its mammographic appearance. Therefore, the extent of removal of a maromographic abnormality does not predict the extent of removal of a histologic abnormality, ¢.g., malignancy. When the sampled mammographic abnormality or the sampled tissue is not histologically Lenign, it is esscntial that the tissus margins be examined for completeness of removal. The device is available in 3, 10, 15 and Z0mm diameters. Device diameter should be matched to desired diameter of tissue sample for diagnosis.

Source page: https://510kreport.com/device/K983296
Methodology: https://510kreport.com/methodology