# K021847: Biopsy Sciences, LLC. Maxi-Cell Biopsy Needles

- Pathway: 510(k) (Traditional)
- Applicant: Biopsy Sciences, LLC
- Decided: Sep 3, 2002 after 90 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: 1 generation back to K822630 (1982). 2 ancestors in all.
11 later devices descend from it; 2 cite it directly.
1 of 14 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K822630: Monoject Plastic Hub Spinal Needle, Sherwood Medical Co. (1982) Summary page 1.
- K851838: Manan Chiba PTC Needle, Manan Manufacturing Co., Inc. (1985) Summary page 1.

## Most influential descendants
- K142688: Echotip Procore HD Ultrasound Biopsy Needle (2014), 9 descendants of its own
- K160229: Echotip Ultra Endobronchial High Definition Ultrasound Needle, Echotip Procore Endobronchial High Definition Ultrasound Biopsy Needle (2016), 7 descendants of its own
- K210476: EchoTip Ultra Endoscopic Ultrasound Needle, EchoTip ProCore HD Ultrasound Biopsy Needle, EchoTip Ultra Endobronchial High Definition Ultrasound Needle, EchoTip ProCore Endobronchial High Definition Ultrasound Biopsy Needle (2021), 2 descendants of its own
- K193517: ViziShot 2 FLEX (2020), 2 descendants of its own
- K230909: EchoTip® AcuCore™ Ultrasound Biopsy Needle (ECHO-BX-3-22) (2023), 1 descendant of its own

## Indications for use
The Biopsy Sciences, LLC., Maxi-Cell Biopsy Needles are intended to be used for fine needle biopsies of various soft organs and tissues, including, but not limited to, biopsies for breast, lung, thyroid, liver, pancreas, spleen, kidneys, and prostate

Source page: https://510kreport.com/device/K021847
Methodology: https://510kreport.com/methodology