# K212819: Disposable Biopsy Refill Needle

- Pathway: 510(k) (Traditional)
- Applicant: Suzhou Leapmed Healthcare Corporation
- Decided: Jul 6, 2022 after 306 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: 4 generations back to K922939 (1993). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160316: SemiCut Semi-automatic Biopsy Needle, Themy Automatic Disposable Biopsy Device, Palium Automatic Reusable Biopsy Device, EasyCut Semi-automatic Biopsy Needle, MDL Biopsy and Coaxial Introducer Needles, M.D.L. S.R.L. (2016) Summary page 4.

## Indications for use
Disposable Biopsy Refill Needle is intended for soft tissue core biopsy from liver,kidney, prostate, breast, spleen, lymph nodes and various soft tissue masses. The device is not intended for use in bone. The extent of histological abnormality cannot be reliably determined from its mammographic appearance. Therefore the extent of removal of the imaged evidence of an abnormality does not predict the extent of removal of a histological abnormality (e.g. malignancy). When the sampled abnormality is not histologically benign, it is essential that the tissue margins be examined for completeness of removal using standard surgical procedures.

Source page: https://510kreport.com/device/K212819
Methodology: https://510kreport.com/methodology