510(k) · Cleared
Recalled · 2008Easy Core Biopsy System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific Corp · FCG Biopsy Needle
Cleared on May 6, 2004 after a 30-day review. The FDA summary names its predicate without a number. 3 later devices descend from it. It has been recalled 19 times.
- Decided
- May 6, 2004
- Review
- 30 days
- Class
- Class II
- Product code
- FCG
- Recalls
- 19
- Predicates
- 0
3 later devices descend from it, 1 citing it directly.
- This deviceK040893 Easy Core Biopsy SystemBoston Scientific Corp · 2004
- Descendant · cites it directly · 2 of its ownK050120 Easy Core Biopsy System IIBoston Scientific Corp · 2005
- Descendant · 2 generations on · 1 of its ownK101832 Biopince Ultra Full Core Biopsy InstrumentMedical Device Technologies, Inc. · 2010
- Descendant · 3 generations on · 0 of its ownK102756 Surecore Biopsy DeviceChest Innovations, Inc. · 2011
Most influential descendants
Showing 3 of 3 · See all- K050120Easy Core Biopsy System IIBoston Scientific Corp · 2005 · cites it directly2descendants
- K101832Biopince Ultra Full Core Biopsy InstrumentMedical Device Technologies, Inc. · 2010 · 2 generations on1descendant
- K102756Surecore Biopsy DeviceChest Innovations, Inc. · 2011 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K040893 | Easy Core Biopsy System | Boston Scientific Corp | 2004 | — |
| +1 | K050120 | Easy Core Biopsy System II | Boston Scientific Corp | 2005 | — |
| +2 | K101832 | Biopince Ultra Full Core Biopsy Instrument | Medical Device Technologies, Inc. | 2010 | — |
| +3 | K102756 | Surecore Biopsy Device | Chest Innovations, Inc. | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in FCG? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new FCG device
- #1 K250994 ClearTip FNA and FNB Typesscore 13.2 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | — | ASAP Biopsy System (Formerly referred to as Stamney Sampler Spring Loaded Needle) Named without a submission number | |
| * | — | ASAP 14g Biopsy System Named without a submission number |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K050120 | Easy Core Biopsy System II | 2005 | 2 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 17, 2008 | Not classified | Z-0487-2009 | Nonconforming Material/Component | These devices may experience difficulty cocking and arming, resulting in an inability to use the devices. |
| Oct 17, 2008 | Not classified | Z-0495-2009 | Nonconforming Material/Component | These devices may experience difficulty cocking and arming, resulting in an inability to use the devices. |
| Oct 17, 2008 | Not classified | Z-0489-2009 | Nonconforming Material/Component | These devices may experience difficulty cocking and arming, resulting in an inability to use the devices. |
| Oct 17, 2008 | Not classified | Z-0490-2009 | Nonconforming Material/Component | These devices may experience difficulty cocking and arming, resulting in an inability to use the devices. |
| Oct 17, 2008 | Not classified | Z-0491-2009 | Nonconforming Material/Component | These devices may experience difficulty cocking and arming, resulting in an inability to use the devices. |
| Oct 17, 2008 | Not classified | Z-0492-2009 | Nonconforming Material/Component | These devices may experience difficulty cocking and arming, resulting in an inability to use the devices. |
| Oct 17, 2008 | Not classified | Z-0488-2009 | Nonconforming Material/Component | These devices may experience difficulty cocking and arming, resulting in an inability to use the devices. |
| Oct 17, 2008 | Not classified | Z-0493-2009 | Nonconforming Material/Component | These devices may experience difficulty cocking and arming, resulting in an inability to use the devices. |
| Oct 17, 2008 | Not classified | Z-0494-2009 | Nonconforming Material/Component | These devices may experience difficulty cocking and arming, resulting in an inability to use the devices. |
| Oct 7, 2008 | Not classified | Z-0331-2009 | Device Design | 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 the device. |
| Oct 7, 2008 | Not classified | Z-0332-2009 | Device Design | 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 the device. |
| Oct 7, 2008 | Not classified | Z-0334-2009 | Device Design | 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 the device. |
| Oct 7, 2008 | Not classified | Z-0336-2009 | Device Design | 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 the device. |
| Oct 7, 2008 | Not classified | Z-0337-2009 | Device Design | 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 the device. |
| Oct 7, 2008 | Not classified | Z-0333-2009 | Device Design | 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 the device. |
| Oct 7, 2008 | Not classified | Z-0328-2009 | Device Design | 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 the device. |
| Oct 7, 2008 | Not classified | Z-0330-2009 | Device Design | 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 the device. |
| Oct 7, 2008 | Not classified | Z-0335-2009 | Device Design | 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 the device. |
| Oct 7, 2008 | Not classified | Z-0329-2009 | Device Design | 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 the device. |
The 5 latest of 19 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K050120 (Boston Scientific Corp, 2005) has gone furthest, with 2 descendants of its own.
How does its category compare?
All FCG devicesFCG Biopsy Needle: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FCG
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FCG
82in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FCG
5in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FCG
632in 2025
MAUDE reports naming product code FCG, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 4 | 32 | 0 | 11 |
| 2008 | 1 | — | 19 | 115 |
| 2009 | 4 | 87 | 5 | 270 |
| 2010 | 3 | 18 | 4 | 73 |
| 2011 | 1 | — | 2 | 71 |
| 2012 | 0 | — | 0 | 107 |
| 2013 | 1 | — | 0 | 130 |
| 2014 | 5 | 88 | 0 | 154 |
| 2015 | 4 | 91 | 0 | 124 |
| 2016 | 3 | 63 | 0 | 191 |
| 2017 | 3 | 166 | 0 | 273 |
| 2018 | 6 | 140 | 0 | 282 |
| 2019 | 0 | — | 0 | 229 |
| 2020 | 1 | — | 0 | 240 |
| 2021 | 1 | — | 5 | 290 |
| 2022 | 2 | — | 0 | 302 |
| 2023 | 4 | 82 | 0 | 428 |
| 2024 | 1 | — | 0 | 446 |
| 2025 | 2 | — | 0 | 632 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040893 · printed Nov 3, 2026
Cite this page
510(k) Report. “K040893: Easy Core Biopsy System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K040893
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026