# K062979: Thyrosampler

- Pathway: 510(k) (Traditional)
- Applicant: Acd Medical Innovation Corp.
- Decided: May 30, 2007 after 243 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Thyrosampler® Kurtaran Frass is indicated for ultrasound guided fine needle aspiration of soft thyroid nodules that are about 1 cm or greater in diameter, located up to depth of 4 cm from the skin.

Source page: https://510kreport.com/device/K062979
Methodology: https://510kreport.com/methodology