# K212822: Disposable Coaxial Biopsy 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 Coaxial Biopsy Needle is intended for use with biopsy devices cannula during soft tissue core biopsy procedures. The device is not intended for use in bone.

Source page: https://510kreport.com/device/K212822
Methodology: https://510kreport.com/methodology