# K013108: Biosuc

- Pathway: 510(k) (Traditional)
- Applicant: Hakko Medical Co., Ltd.
- Decided: Apr 4, 2002 after 199 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 K831392 (1983). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K943651: Techna-Cut Aspiration Needle, Manan Medical Products, Inc. (1994) Summary page 1.
- K831392: Tru-Cut Biopsy/Aspira-Needle 2N2709, Travenol Laboratories, S.A. (1983) Summary page 1.
- K974575: Daum Aspirationbiopsy Needle, Daum Corp. (1998) Summary page 1.

## Indications for use
The BioSuc Fine Aspiration Cytology Needle is indicated for the biopsy of tumors in the Thyroid, Breast or Lymph node.

Source page: https://510kreport.com/device/K013108
Methodology: https://510kreport.com/methodology