510(k) · Cleared
ClearedGip/Medi-Globe Sclerotherapy Needles
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medi-Globe Corp. · FBK Endoscopic Injection Needle, Gastroenterology-Urology
Cleared on Feb 29, 1996 after an 85-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 20 later devices descend from it.
- Decided
- Feb 29, 1996
- Review
- 85 days
- Class
- Class II
- Product code
- FBK
- Recalls
- None
- Predicates
- 0
20 later devices descend from it, 2 citing it directly.
- This deviceK955558 Gip/Medi-Globe Sclerotherapy NeedlesMedi-Globe Corp. · 1996
- Descendant · cites it directly · 16 of its ownK061222 Injectra Injection NeedleMedi-Globe Corp. · 2006
- Descendant · 2 generations on · 7 of its ownK150434 Injection NeedleMicro-Tech (Nanjing) Co., Ltd. · 2015
- Descendant · 2 generations on · 6 of its ownK132065 Injection NeedleEndochoice, Inc. · 2014
- Descendant · 3 generations on · 4 of its ownK153625 Single Use Injector NM600/610Olympus Medical Systems Corp. · 2016 · Recalled
- Descendant · 3 generations on · 3 of its ownK210917 Single Use Injection NeedleAnrei Medical (Hangzhou) Co., Ltd. · 2021
Showing 5 of 20 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 20 · See all- K061222Injectra Injection NeedleMedi-Globe Corp. · 2006 · cites it directly16descendants
- K150434Injection NeedleMicro-Tech (Nanjing) Co., Ltd. · 2015 · 2 generations on7descendants
- K132065Injection NeedleEndochoice, Inc. · 2014 · 2 generations on6descendants
- K153625Single Use Injector NM600/610Olympus Medical Systems Corp. · 2016 · 3 generations on4descendants
- K210917Single Use Injection NeedleAnrei Medical (Hangzhou) Co., Ltd. · 2021 · 3 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K955558 | Gip/Medi-Globe Sclerotherapy Needles | Medi-Globe Corp. | 1996 | — |
| +1 | K061222 | Injectra Injection Needle | Medi-Globe Corp. | 2006 | — |
| +2 | K150434 | Injection Needle | Micro-Tech (Nanjing) Co., Ltd. | 2015 | — |
| +2 | K132065 | Injection Needle | Endochoice, Inc. | 2014 | — |
| +3 | K153625 | Single Use Injector NM600/610 | Olympus Medical Systems Corp. | 2016 | 20 |
| +3 | K210917 | Single Use Injection Needle | Anrei Medical (Hangzhou) Co., Ltd. | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2011 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 3 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 2 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in FBK? 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 FBK device
- #1 K253598 InjecSURE Injection Systemscore 12.9 · 7 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (20)
See all 202 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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K061222 (Medi-Globe Corp., 2006) has gone furthest, with 16 descendants of its own.
How does its category compare?
All FBK devicesFBK Endoscopic Injection Needle, Gastroenterology-Urology: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FBK
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FBK
155in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FBK
9in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FBK
81in 2025
MAUDE reports naming product code FBK, 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 | 0 | — | 0 | 3 |
| 2008 | 1 | — | 0 | 22 |
| 2009 | 4 | 101 | 0 | 12 |
| 2010 | 0 | — | 0 | 12 |
| 2011 | 1 | — | 0 | 2 |
| 2012 | 2 | — | 0 | 2 |
| 2013 | 0 | — | 0 | 3 |
| 2014 | 2 | — | 0 | 9 |
| 2015 | 3 | 103 | 0 | 4 |
| 2016 | 2 | — | 1 | 18 |
| 2017 | 3 | 51 | 0 | 27 |
| 2018 | 2 | — | 0 | 9 |
| 2019 | 1 | — | 0 | 6 |
| 2020 | 2 | — | 0 | 25 |
| 2021 | 1 | — | 20 | 34 |
| 2022 | 6 | 213 | 8 | 80 |
| 2023 | 3 | 177 | 1 | 60 |
| 2024 | 4 | 192 | 9 | 94 |
| 2025 | 3 | 155 | 0 | 81 |
| 2026 | 2 | — | 1 | — |
https://510kreport.com/device/K955558 · printed Nov 6, 2026
Cite this page
510(k) Report. “K955558: Gip/Medi-Globe Sclerotherapy Needles.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K955558
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026