510(k) · Cleared
ClearedSonotip II Ultrasound Needle System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medi-Globe Corporation · FCG Biopsy Needle
Cleared on Jan 31, 2007 as substantially equivalent to K990220 (Medi-Globe Corp., 1999) and 1 other predicate after a 15-day review. Its family tree reaches back 3 generations to 1995. 1 of the 61 devices in its family, counting itself, has a Class I recall. 57 later devices descend from it.
- Decided
- Jan 31, 2007
- Review
- 15 days
- Class
- Class II
- Product code
- FCG
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K935844 (1995). 57 later devices descend from it, 4 citing it directly. 1 of the 61 devices in this family, counting this one, has a Class I recall.
- Root · 3 generations backK935844 Gip/Medi-Globe Needle System for Ultrasonic FnaMedi-Globe Corp. · 1995
- 2 generations backK990220 Modification of Gip/Medi-Globe Ultrasound Needle SystemMedi-Globe Corp. · 1999
- 1 generation backK051247 Sonotip II Ultrasound Needle SystemMedi-Globe Corp. · 2005
- This deviceK070129 Sonotip II Ultrasound Needle SystemMedi-Globe Corporation · 2007
- Descendant · cites it directly · 49 of its ownK083330 Echotip Ultra Ultrasound NeedleCook Endoscopy · 2009
- Descendant · 2 generations on · 16 of its ownK092359 Echo Tip Ultra High Definition Ultrasound Access Needle, Model…Cook Ireland, Ltd. · 2009 · Recalled
- Descendant · 2 generations on · 11 of its ownK123676 Cellvizio 100 Series and Cellvizio Systems with Confocal MiniprobesMauna Kea Technologies · 2013
- Descendant · 3 generations on · 10 of its ownK132389 Cellvizio 100 Series System and Cellvizio System with Confocal…Daniel & Daniel Consulting · 2014
- Descendant · 2 generations on · 10 of its ownK111895 Echotip (R) Ultra Fiducial NeedleWilson-Cook Medical Inc./Cook Endoscopy · 2012
Showing 5 of 57 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K193517 ViziShot 2 FLEX4 generations on · 2020
Most influential descendants
Showing 5 of 57 · See all- K083330Echotip Ultra Ultrasound NeedleCook Endoscopy · 2009 · cites it directly49descendants
- K092359Echo Tip Ultra High Definition Ultrasound Access Needle, Model: Echo-HD-19ACook Ireland, Ltd. · 2009 · 2 generations on16descendants
- K123676Cellvizio 100 Series and Cellvizio Systems with Confocal MiniprobesMauna Kea Technologies · 2013 · 2 generations on11descendants
- K132389Cellvizio 100 Series System and Cellvizio System with Confocal Miniprobes; Uroflex B and…Daniel & Daniel Consulting · 2014 · 3 generations on10descendants
- K111895Echotip (R) Ultra Fiducial NeedleWilson-Cook Medical Inc./Cook Endoscopy · 2012 · 2 generations on10descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K935844 | Gip/Medi-Globe Needle System for Ultrasonic Fna | Medi-Globe Corp. | 1995 | — |
| −2 | K990220 | Modification of Gip/Medi-Globe Ultrasound Needle System | Medi-Globe Corp. | 1999 | — |
| −1 | K051247 | Sonotip II Ultrasound Needle System | Medi-Globe Corp. | 2005 | — |
| 0 (this device) | K070129 | Sonotip II Ultrasound Needle System | Medi-Globe Corporation | 2007 | — |
| +1 | K083330 | Echotip Ultra Ultrasound Needle | Cook Endoscopy | 2009 | — |
| +2 | K092359 | Echo Tip Ultra High Definition Ultrasound Access Needle, Model: Echo-HD-19A | Cook Ireland, Ltd. | 2009 | 1 |
| +2 | K123676 | Cellvizio 100 Series and Cellvizio Systems with Confocal Miniprobes | Mauna Kea Technologies | 2013 | — |
| +3 | K132389 | Cellvizio 100 Series System and Cellvizio System with Confocal Miniprobes… | Daniel & Daniel Consulting | 2014 | — |
| +2 | K111895 | Echotip (R) Ultra Fiducial Needle | Wilson-Cook Medical Inc./Cook Endoscopy | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 4 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 3 | 0 |
| 2014 | 7 | 0 |
| 2015 | 4 | 0 |
| 2016 | 2 | 0 |
| 2017 | 6 | 0 |
| 2018 | 3 | 0 |
| 2019 | 2 | 0 |
| 2020 | 7 | 1 |
| 2021 | 3 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 3 | 0 |
| 2025 | 3 | 0 |
| 2026 | 3 | 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 |
|---|---|---|---|
| * | K990220 | Modification of Gip/Medi-Globe Ultrasound Needle SystemSummary page 1…Number: (480) 897-2878 B. Device Name: Medi-Globe SonoTip II Ultrasound Needle System C. Predicate Devices: GIP/Medi-Globe GI Ultrasound Needle System (K990220) Medi-Globe SonoTip II Ultrasound Needle System (KO51247) D. Device Description: The SonoTip II Endoscopic Ultraso… | 1999 |
| * | K051247 | Sonotip II Ultrasound Needle System | 2005 |
What descends from it? (57)
See all 574 later devices cite it directly; ranked here by how many devices descend from each in turn.
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.
- K193517ViziShot 2 FLEXOlympus Surgical Technologies America · 2020 · 4 generations on · ◆ in the 2020 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 12 years and passes through 2 companies; a new generation was cleared every 4.1 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K083330 (Cook Endoscopy, 2009) has gone furthest, with 49 descendants of its own.
- 1 other device also cites its predicate K990220.
How does its category compare?
All FCG devicesFCG Biopsy Needle: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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?
The SonoTip II Ultrasound Needle System is used in conjunction with various legally marketed, FDA registered Ultrasound Endoscopes. The SonoTip II Needle System is used for ultrasonically guided fine needle aspiration, (FNA) of submucosal and extra-luminal lesions of the Gastrointestinal tract (i.e., pancreatic masses, mediastinal masses, peri-pancreatic masses and lymph nodes.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070129 · printed Nov 6, 2026
Cite this page
510(k) Report. “K070129: Sonotip II Ultrasound Needle System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070129
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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