510(k) · Cleared
ClearedEchoTip AcuCore™ EUS Biopsy Needle (ECHO-BX-19)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cook Ireland, Ltd. · FCG Biopsy Needle
Cleared on Jul 29, 2024 as substantially equivalent to K230909 (Cook Ireland, Ltd., 2023) and 1 other predicate after a 90-day review. Its family tree reaches back 13 generations to 1989. 1 of the 71 devices in its family, counting itself, has a Class I recall.
- Decided
- Jul 29, 2024
- Review
- 90 days
- Class
- Class II
- Product code
- FCG
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 13 generations to K894632 (1989). 70 ancestors in all, the oldest K812810 (1981). No later device cites it as a predicate yet. 1 of the 71 devices in this family, counting this one, has a Class I recall.
- Root · 13 generations backK894632 Model SSH-140A Ultrasound Imaging SystemToshiba America Medical Systems, In.C · 1989
- 9 generations between
- 3 generations backK160229 Echotip Ultra Endobronchial High Definition Ultrasound Needle…Cook Ireland, Ltd. · 2016
- 2 generations backK210476 EchoTip Ultra Endoscopic Ultrasound Needle, EchoTip ProCore HD…Cook Ireland, Ltd. · 2021 · Recalled
- 1 generation backK230909 EchoTip® AcuCore™ Ultrasound Biopsy Needle (ECHO-BX-3-22)Cook Ireland, Ltd. · 2023
- This deviceK241209 EchoTip AcuCore™ EUS Biopsy Needle (ECHO-BX-19)Cook Ireland, Ltd. · 2024
Show all 13 generations
- Root · 13 generations backK894632 Model SSH-140A Ultrasound Imaging SystemToshiba America Medical Systems, In.C · 1989
- 12 generations backK941593 Diagnostic Ultrasonic TransducerToshiba America Medical Systems, In.C · 1996
- 11 generations backK970047 Phased Array Transducer - - PSK-20CTToshiba America Medical Systems, In.C · 1997
- 10 generations backK991710 Ssa-370A/Powervision 6000Toshiba America Medical Systems, In.C · 1999
- 9 generations backK994096 Sonoheart Hand-Carried Echocardiography SystemSonosite,Inc. · 1999
- 8 generations backK010591 Olympus EU-C60 Eus Exera Compact Endoscopic Ultrasound CenterOlympus Optical Co., Ltd. · 2001 · Recalled
- 7 generations backK031347 Ultrasonic Gastrovideoscope, Type UC160P-AT8 and UCT160-AT8Olympus Optical Co., Ltd. · 2003
- 6 generations backK042140 Olympus BF Type UC160-OL8Olympus Corporation · 2004 · Recalled
- 5 generations backK050503 Single Use Aspiration Needle NA-201SX-4022Olympus Medical Systems Corporation · 2005 · Recalled
- 4 generations backK093195 Echotip Ultra Endobronchial High Definition Ultasound Needle, Model…Cook Ireland, Ltd. · 2010
- 3 generations backK160229 Echotip Ultra Endobronchial High Definition Ultrasound Needle…Cook Ireland, Ltd. · 2016
- 2 generations backK210476 EchoTip Ultra Endoscopic Ultrasound Needle, EchoTip ProCore HD…Cook Ireland, Ltd. · 2021 · Recalled
- 1 generation backK230909 EchoTip® AcuCore™ Ultrasound Biopsy Needle (ECHO-BX-3-22)Cook Ireland, Ltd. · 2023
- This deviceK241209 EchoTip AcuCore™ EUS Biopsy Needle (ECHO-BX-19)Cook Ireland, Ltd. · 2024
Class I recalls in this family
- K023984 Modification to Olympus Bronchoscopes BF-40…7 generations back · 2003
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K894632 | Model SSH-140A Ultrasound Imaging System | Toshiba America Medical Systems, In.C | 1989 | — |
| −12 | K941593 | Diagnostic Ultrasonic Transducer | Toshiba America Medical Systems, In.C | 1996 | — |
| −11 | K970047 | Phased Array Transducer - - PSK-20CT | Toshiba America Medical Systems, In.C | 1997 | — |
| −10 | K991710 | Ssa-370A/Powervision 6000 | Toshiba America Medical Systems, In.C | 1999 | — |
| −9 | K994096 | Sonoheart Hand-Carried Echocardiography System | Sonosite,Inc. | 1999 | — |
| −8 | K010591 | Olympus EU-C60 Eus Exera Compact Endoscopic Ultrasound Center | Olympus Optical Co., Ltd. | 2001 | 2 |
| −7 | K031347 | Ultrasonic Gastrovideoscope, Type UC160P-AT8 and UCT160-AT8 | Olympus Optical Co., Ltd. | 2003 | — |
| −6 | K042140 | Olympus BF Type UC160-OL8 | Olympus Corporation | 2004 | 1 |
| −5 | K050503 | Single Use Aspiration Needle NA-201SX-4022 | Olympus Medical Systems Corporation | 2005 | 5 |
| −4 | K093195 | Echotip Ultra Endobronchial High Definition Ultasound Needle, Model… | Cook Ireland, Ltd. | 2010 | — |
| −3 | K160229 | Echotip Ultra Endobronchial High Definition Ultrasound Needle, Echotip Procore… | Cook Ireland, Ltd. | 2016 | — |
| −2 | K210476 | EchoTip Ultra Endoscopic Ultrasound Needle, EchoTip ProCore HD Ultrasound… | Cook Ireland, Ltd. | 2021 | 1 |
| −1 | K230909 | EchoTip® AcuCore™ Ultrasound Biopsy Needle (ECHO-BX-3-22) | Cook Ireland, Ltd. | 2023 | — |
| 0 (this device) | K241209 | EchoTip AcuCore™ EUS Biopsy Needle (ECHO-BX-19) | Cook Ireland, Ltd. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1982 | 1 | 0 |
| 1985 | 1 | 0 |
| 1986 | 1 | 0 |
| 1988 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 2 | 0 |
| 1992 | 1 | 0 |
| 1993 | 4 | 0 |
| 1994 | 5 | 0 |
| 1995 | 4 | 0 |
| 1996 | 4 | 0 |
| 1997 | 9 | 0 |
| 1998 | 4 | 0 |
| 1999 | 3 | 0 |
| 2000 | 3 | 0 |
| 2001 | 2 | 0 |
| 2002 | 3 | 0 |
| 2003 | 2 | 1 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2014 | 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.
1 device in this family has a Class I recall. 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 |
|---|---|---|---|
| * | K230909 | EchoTip® AcuCore™ Ultrasound Biopsy Needle (ECHO-BX-3-22)Summary page 5…lass II Product Code: FCG Panel: Gastroenterology/Urology Predicate Device: Primary Predicate: EchoTip AcuCore™ EUS Biopsy Needle (K230909, Cook Ireland Ltd) Reference Predicate: EchoTip ProCore® HD Ultrasound Biopsy Needle (K210476, Cook Ireland Ltd) Device Descrip… | 2023 |
| * | K210476 | EchoTip Ultra Endoscopic Ultrasound Needle, EchoTip ProCore HD Ultrasound Biopsy Needle…Summary page 5…Predicate Device: Primary Predicate: EchoTip AcuCore™ EUS Biopsy Needle (K230909, Cook Ireland Ltd) Reference Predicate: EchoTip ProCore® HD Ultrasound Biopsy Needle (K210476, Cook Ireland Ltd) Device Description: The EchoTip AcuCore™ EUS Biopsy Needle (ECHO-BX-19) is an endoscopic ultrasound needle co… | 2021 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K023984Modification to Olympus Bronchoscopes BF-40 Series, BF-240 Series, and BF-160 SeriesThe Olympus Optical Co. · 2003 · 7 generations back · ◆ in the 2003 ancestors bar of FIG. 114 Class I recalls
What does this lineage say?
- The line of descent spans 35 years and passes through 6 companies; a new generation was cleared every 2.0 years on median.
- 18 of the 70 ancestors have a recall of any class; 1 has a Class I recall.
How does its category compare?
All FCG devicesFCG Biopsy Needle: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
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?
This device is used with an ultrasound endoscope for fine needle biopsy (FNB), of submucosal and extramural lesions, mediastinal masses, lymph nodes, and intraperitoneal masses within or adjacent to the gastrointestinal tract.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K241209 · printed Nov 5, 2026
Cite this page
510(k) Report. “K241209: EchoTip AcuCore™ EUS Biopsy Needle (ECHO-BX-19).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K241209
Report an extraction error
Are you the manufacturer?
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