# K963825: Auto Suture* Abbi* System

- Pathway: 510(k) (Traditional)
- Applicant: United States Surgical, A Division of Tyco Healthc
- Decided: Dec 20, 1996 after 87 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 K871390 (1987). 1 ancestor in all.
6 later devices descend from it; 2 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)
- K871390: Bard Biopty Biopsy System, C.R. Bard, Inc. (1987) Summary page 1.

## Most influential descendants
- K983296: Auto Suture Abbi System (1999), 5 descendants of its own
- 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

## Indications for use
Like the Bard Biopsy Needle (K871390), the Auto Suture* ABBI* Breast Biopsy System is intended for obtaining biopsies from breast tissues for diagnostic purposes. The device is not intended for therapeutic excision of tissue.

Source page: https://510kreport.com/device/K963825
Methodology: https://510kreport.com/methodology