# K141894: Sharkcore Fine Needle Biopsy System

- Pathway: 510(k) (Traditional)
- Applicant: Covidien, LLC ( Formerly Beacon Endoscopic Corp.)
- Decided: Oct 6, 2014 after 84 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: 7 generations back to K935844 (1995). 14 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133008: BNX Delivery System Pre-Loaded with 19, 22 and 25 Gauge Needle, 19, 22 or 25 Gauge Needles (Individually Sterile-Packed,, Beacon Endoscopic (2013) Summary page 5.
- K083330: Echotip Ultra Ultrasound Needle, Cook Endoscopy (2009) Summary page 5.

## Most influential descendants
- K150891: BNX Fine Needle Aspiration System and SharkCore LG Fine Needle Biopsy System (2015), 3 descendants of its own
- K163058: Expect Slimline (SL) Endoscopic Ultrasound Aspiration Needle (2017), 1 descendant of its own
- K173184: Expect Slimline (SL) Endoscopic Ultrasound Aspiration Needle (2017), 0 descendants of its own
- K152586: Beacon Fine Needle Fiducial System (2015), 0 descendants of its own

## Indications for use
The SharkCore™ Fine Needle Biopsy System is used with an ultrasound endoscope for fine needle biopsy, (FNB), of submucosal lesions, mediastinal masses, lymph nodes and intaperitoneal masses within or adjacent to the gastrointestinal tract. The needle is designed with a passive (i.e., automatic) safety shielding feature to aid in the prevention of needle stick injury.

Source page: https://510kreport.com/device/K141894
Methodology: https://510kreport.com/methodology