510(k) · Cleared
ClearedSonotip II 25-Gauge Ultrasound Needle System, Models Gus-01-18-025 and Gus-01-27-025
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 Mar 20, 2009 as substantially equivalent to K070129 (Medi-Globe Corporation, 2007) and 2 other predicates after an 88-day review. Its family tree reaches back 4 generations to 1995. 2 later devices descend from it.
- Decided
- Mar 20, 2009
- Review
- 88 days
- Class
- Class II
- Product code
- FCG
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K935844 (1995). 7 ancestors in all, the oldest K926559 (1993). 2 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK935844 Gip/Medi-Globe Needle System for Ultrasonic FnaMedi-Globe Corp. · 1995
- 3 generations backK990220 Modification of Gip/Medi-Globe Ultrasound Needle SystemMedi-Globe Corp. · 1999
- 2 generations backK051247 Sonotip II Ultrasound Needle SystemMedi-Globe Corp. · 2005
- 1 generation backK070129 Sonotip II Ultrasound Needle SystemMedi-Globe Corporation · 2007
- This deviceK083802 Sonotip II 25-Gauge Ultrasound Needle System, Models Gus-01-18-025…Medi-Globe Corporation · 2009
- Descendant · cites it directly · 1 of its ownK172309 Endoscopic Ultrasound Aspiration NeedleMicro-Tech (Nanjing) Co., Ltd. · 2017 · Recalled
- Descendant · 2 generations on · 0 of its ownK212852 Areus (TM) Adapt Endoscopic Ultrasound Aspiration Needle, Tridemt…Micro-Tech (Nanjing) Co., Ltd. · 2021
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K935844 | Gip/Medi-Globe Needle System for Ultrasonic Fna | Medi-Globe Corp. | 1995 | — |
| −3 | K990220 | Modification of Gip/Medi-Globe Ultrasound Needle System | Medi-Globe Corp. | 1999 | — |
| −2 | K051247 | Sonotip II Ultrasound Needle System | Medi-Globe Corp. | 2005 | — |
| −1 | K070129 | Sonotip II Ultrasound Needle System | Medi-Globe Corporation | 2007 | — |
| 0 (this device) | K083802 | Sonotip II 25-Gauge Ultrasound Needle System, Models Gus-01-18-025 and… | Medi-Globe Corporation | 2009 | — |
| +1 | K172309 | Endoscopic Ultrasound Aspiration Needle | Micro-Tech (Nanjing) Co., Ltd. | 2017 | 2 |
| +2 | K212852 | Areus (TM) Adapt Endoscopic Ultrasound Aspiration Needle, Tridemt (TM)… | Micro-Tech (Nanjing) Co., Ltd. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2021 | 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? (3)
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 |
|---|---|---|---|
| * | K070129 | Sonotip II Ultrasound Needle SystemSummary page 1…diglobe.com B. Device Name: Medi-Gl1be SonoTip 1 25-gauge Ultrasound Needle System C. Predicate Devices: Medi-Globe SonoTip 11 Ultrasound Needle System (K070129) Medi-Globe SonoTip II Ultrasound Needle System (K051247) Wilson-Cook Ultrasound Biopsy Needle (KO 13356) D. Devi… | 2007 |
| * | K051247 | Sonotip II Ultrasound Needle SystemSummary page 1…uge Ultrasound Needle System C. Predicate Devices: Medi-Globe SonoTip 11 Ultrasound Needle System (K070129) Medi-Globe SonoTip II Ultrasound Needle System (K051247) Wilson-Cook Ultrasound Biopsy Needle (KO 13356) D. Device Description: The Medi-Globe SonoTip II 25-gauge Ultras… | 2005 |
| * | K013356 | Wilson-Cook Ultrasound Biopsy Needle | 2001 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K172309 | Endoscopic Ultrasound Aspiration Needle | 2017 | 1 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 14 years and passes through 2 companies; a new generation was cleared every 4.1 years on median.
- 1 of the 7 ancestors has a recall of any class.
- Of its descendants, K172309 (Micro-Tech (Nanjing) Co., Ltd., 2017) has gone furthest, with 1 descendant of its own.
- 3 other devices also cite its predicate K070129.
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?
The SonoTip II25-gauge 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/K083802 · printed Nov 5, 2026
Cite this page
510(k) Report. “K083802: Sonotip II 25-Gauge Ultrasound Needle System, Models Gus-01-18-025 and Gus-01-27-025.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K083802
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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