510(k) · Cleared
Recalled · Class II · 2024Echo Tip Ultra High Definition Ultrasound Access Needle, Model: Echo-HD-19A
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 Nov 2, 2009 as substantially equivalent to K083330 (Cook Endoscopy, 2009) and 1 other predicate after a 90-day review. Its family tree reaches back 5 generations to 1995. 16 later devices descend from it. It has been recalled once.
- Decided
- Nov 2, 2009
- Review
- 90 days
- Class
- Class II
- Product code
- FCG
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 5 generations to K935844 (1995). 12 ancestors in all, the oldest K934356 (1994). 16 later devices descend from it, 4 citing it directly.
- Root · 5 generations backK935844 Gip/Medi-Globe Needle System for Ultrasonic FnaMedi-Globe Corp. · 1995
- 4 generations backK990220 Modification of Gip/Medi-Globe Ultrasound Needle SystemMedi-Globe Corp. · 1999
- 3 generations backK051247 Sonotip II Ultrasound Needle SystemMedi-Globe Corp. · 2005
- 2 generations backK070129 Sonotip II Ultrasound Needle SystemMedi-Globe Corporation · 2007
- 1 generation backK083330 Echotip Ultra Ultrasound NeedleCook Endoscopy · 2009
- This deviceK092359 Echo Tip Ultra High Definition Ultrasound Access Needle, Model…Cook Ireland, Ltd. · 2009
- Descendant · cites it directly · 11 of its ownK123676 Cellvizio 100 Series and Cellvizio Systems with Confocal MiniprobesMauna Kea Technologies · 2013
- Descendant · 2 generations on · 10 of its ownK132389 Cellvizio 100 Series System and Cellvizio System with Confocal…Daniel & Daniel Consulting · 2014
- Descendant · 3 generations on · 9 of its ownK141358 Cellvizio 100 Series with System Confocal MiniprobesMauna Kea Technologies · 2014
- Descendant · 4 generations on · 7 of its ownK160416 CystoFlex UHD R-C, CelioFlex UHD 5-C, Cellvizio 100 Series (800)…Mauna Kea Technologies · 2016
- Descendant · 2 generations on · 7 of its ownK150831 Cellvizio 100 Series System with Confocal MiniprobesMauna Kea Technologies · 2015
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 16 · See all- K123676Cellvizio 100 Series and Cellvizio Systems with Confocal MiniprobesMauna Kea Technologies · 2013 · cites it directly11descendants
- K132389Cellvizio 100 Series System and Cellvizio System with Confocal Miniprobes; Uroflex B and…Daniel & Daniel Consulting · 2014 · 2 generations on10descendants
- K141358Cellvizio 100 Series with System Confocal MiniprobesMauna Kea Technologies · 2014 · 3 generations on9descendants
- K160416CystoFlex UHD R-C, CelioFlex UHD 5-C, Cellvizio 100 Series (800) with Confocal MiniprobesMauna Kea Technologies · 2016 · 4 generations on7descendants
- K150831Cellvizio 100 Series System with Confocal MiniprobesMauna Kea Technologies · 2015 · 2 generations on7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K935844 | Gip/Medi-Globe Needle System for Ultrasonic Fna | Medi-Globe Corp. | 1995 | — |
| −4 | K990220 | Modification of Gip/Medi-Globe Ultrasound Needle System | Medi-Globe Corp. | 1999 | — |
| −3 | K051247 | Sonotip II Ultrasound Needle System | Medi-Globe Corp. | 2005 | — |
| −2 | K070129 | Sonotip II Ultrasound Needle System | Medi-Globe Corporation | 2007 | — |
| −1 | K083330 | Echotip Ultra Ultrasound Needle | Cook Endoscopy | 2009 | — |
| 0 (this device) | K092359 | Echo Tip Ultra High Definition Ultrasound Access Needle, Model: Echo-HD-19A | Cook Ireland, Ltd. | 2009 | — |
| +1 | K123676 | Cellvizio 100 Series and Cellvizio Systems with Confocal Miniprobes | Mauna Kea Technologies | 2013 | — |
| +2 | K132389 | Cellvizio 100 Series System and Cellvizio System with Confocal Miniprobes… | Daniel & Daniel Consulting | 2014 | — |
| +3 | K141358 | Cellvizio 100 Series with System Confocal Miniprobes | Mauna Kea Technologies | 2014 | — |
| +4 | K160416 | CystoFlex UHD R-C, CelioFlex UHD 5-C, Cellvizio 100 Series (800) with Confocal… | Mauna Kea Technologies | 2016 | — |
| +2 | K150831 | Cellvizio 100 Series System with Confocal Miniprobes | Mauna Kea Technologies | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1997 | 3 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 3 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K083330 | Echotip Ultra Ultrasound NeedleSummary page 1…, biopsy (21 CFR 876.1075, Product Code: FCG) Legally Marketed Devices: EchoTip® Ultra Ultrasound Needle (K083330) TM Wilson-Coo… | 2009 |
| * | K022595 | Wilson-Cook CystotomeSummary page 1…TM Wilson-Cook Cystotome Needle Knife (K022595) Description of the Device: The EchoTip® Ultra High Definition Ultrasound… | 2002 |
What descends from it? (16)
See all 164 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 1, 2024 | Class II | Z-1832-2024 | Nonconforming Material/Component | Devices may contain elevated levels of bacterial endotoxin. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 14 years and passes through 4 companies; a new generation was cleared every 2.0 years on median.
- 1 of the 12 ancestors has a recall of any class.
- Of its descendants, K123676 (Mauna Kea Technologies, 2013) has gone furthest, with 11 descendants of its own.
- 8 other devices also cite its predicate K083330.
How does its category compare?
All FCG devicesFCG Biopsy Needle: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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 to access or sample submucosal and extramural lesions of the gastrointestinal tract, access of the following: the intra- or extra-hepatic bile ducts, pancreatic ducts, cystic duct, gallbladder or for delivery of injectable materials into tissues through the accessory channel of an ultrasound endoscope.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092359 · printed Nov 4, 2026
Cite this page
510(k) Report. “K092359: Echo Tip Ultra High Definition Ultrasound Access Needle, Model: Echo-HD-19A.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K092359
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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