# K040893: Easy Core Biopsy System

- Pathway: 510(k) (Special)
- Applicant: Boston Scientific Corp
- Decided: May 6, 2004 after 30 days
- Product code: FCG (Biopsy Needle)
- Device class: 2
- Regulation: 21 CFR 876.1075
- Recalls of this device: 19 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) ASAP Biopsy System (Formerly referred to as Stamney Sampler Spring Loaded Needle): named in the summary without a submission number
- (no number) ASAP 14g Biopsy System: named in the summary without a submission number

## Most influential descendants
- K050120: Easy Core Biopsy System II (2005), 2 descendants of its own
- K101832: Biopince Ultra Full Core Biopsy Instrument (2010), 1 descendant of its own
- K102756: Surecore Biopsy Device (2011), 0 descendants of its own

## Recalls of this device
- Oct 17, 2008 · Not classified · Z-0487-2009: These devices may experience difficulty cocking and arming, resulting in an inability to use the devices.
- Oct 17, 2008 · Not classified · Z-0495-2009: These devices may experience difficulty cocking and arming, resulting in an inability to use the devices.
- Oct 17, 2008 · Not classified · Z-0489-2009: These devices may experience difficulty cocking and arming, resulting in an inability to use the devices.
- Oct 17, 2008 · Not classified · Z-0490-2009: These devices may experience difficulty cocking and arming, resulting in an inability to use the devices.
- Oct 17, 2008 · Not classified · Z-0491-2009: These devices may experience difficulty cocking and arming, resulting in an inability to use the devices.
- Oct 17, 2008 · Not classified · Z-0492-2009: These devices may experience difficulty cocking and arming, resulting in an inability to use the devices.
- Oct 17, 2008 · Not classified · Z-0488-2009: These devices may experience difficulty cocking and arming, resulting in an inability to use the devices.
- Oct 17, 2008 · Not classified · Z-0493-2009: These devices may experience difficulty cocking and arming, resulting in an inability to use the devices.
- Oct 17, 2008 · Not classified · Z-0494-2009: These devices may experience difficulty cocking and arming, resulting in an inability to use the devices.
- Oct 7, 2008 · Not classified · Z-0331-2009: Boston Scientific Corporation initiated a recall of its easy Core" BIOPSY SYSTEM due to difficulty cocking or arming the cannula latch on the device. This difficulty may result in an inability to use 
- Oct 7, 2008 · Not classified · Z-0332-2009: Boston Scientific Corporation initiated a recall of its easy Core" BIOPSY SYSTEM due to difficulty cocking or arming the cannula latch on the device. This difficulty may result in an inability to use 
- Oct 7, 2008 · Not classified · Z-0334-2009: Boston Scientific Corporation initiated a recall of its easy Core" BIOPSY SYSTEM due to difficulty cocking or arming the cannula latch on the device. This difficulty may result in an inability to use 
- Oct 7, 2008 · Not classified · Z-0336-2009: Boston Scientific Corporation initiated a recall of its easy Core" BIOPSY SYSTEM due to difficulty cocking or arming the cannula latch on the device. This difficulty may result in an inability to use 
- Oct 7, 2008 · Not classified · Z-0337-2009: Boston Scientific Corporation initiated a recall of its easy Core" BIOPSY SYSTEM due to difficulty cocking or arming the cannula latch on the device. This difficulty may result in an inability to use 
- Oct 7, 2008 · Not classified · Z-0333-2009: Boston Scientific Corporation initiated a recall of its easy Core" BIOPSY SYSTEM due to difficulty cocking or arming the cannula latch on the device. This difficulty may result in an inability to use 
- Oct 7, 2008 · Not classified · Z-0328-2009: Boston Scientific Corporation initiated a recall of its easy Core" BIOPSY SYSTEM due to difficulty cocking or arming the cannula latch on the device. This difficulty may result in an inability to use 
- Oct 7, 2008 · Not classified · Z-0330-2009: Boston Scientific Corporation initiated a recall of its easy Core" BIOPSY SYSTEM due to difficulty cocking or arming the cannula latch on the device. This difficulty may result in an inability to use 
- Oct 7, 2008 · Not classified · Z-0335-2009: Boston Scientific Corporation initiated a recall of its easy Core" BIOPSY SYSTEM due to difficulty cocking or arming the cannula latch on the device. This difficulty may result in an inability to use 
- Oct 7, 2008 · Not classified · Z-0329-2009: Boston Scientific Corporation initiated a recall of its easy Core" BIOPSY SYSTEM due to difficulty cocking or arming the cannula latch on the device. This difficulty may result in an inability to use 

## Indications for use
The Easy Core Biopsy System is indicated for use endoscopically or percutaneously to retrieve tissue sampling of soft organs/tumors or masses for histological analysis. Soft tissue sampling includes but not limited to organs such as breast, liver, kidney and prostate.

Source page: https://510kreport.com/device/K040893
Methodology: https://510kreport.com/methodology