# K013109: Sonopsy

- Pathway: 510(k) (Traditional)
- Applicant: Hakko Medical Co., Ltd.
- Decided: Mar 12, 2002 after 176 days
- Product code: FCG (Biopsy Needle)
- 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 K895897 (1989). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K981166: Accucore Core Biopsy Needle Catalog Codes:581014, 581614, 581618, 582018, 582518, 581620, 582020, 581214, Inrad (1998) Summary page 1.
- K882601: E-Z-EM (R) Lufkin Biopsy Needles, E-Z-Em, Inc. (1988) Summary page 1.
- K974575: Daum Aspirationbiopsy Needle, Daum Corp. (1998) Summary page 1.

## Indications for use
The Sonopsy aspiration needle is intended to percutaneously obtain abdominal tissue including the liver prostate, kidney, breast, lymph node, and other soft tissues using ultrasonic visualization.

Source page: https://510kreport.com/device/K013109
Methodology: https://510kreport.com/methodology