510(k) · Cleared
ClearedMicrovasive Injection Gold Probe
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific Corp · KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
Cleared on Nov 2, 1994 as substantially equivalent to K885005 (Boston Scientific Corp, 1989) and 1 other predicate after a 174-day review. Its family tree reaches back 1 generation to 1985. 6 later devices descend from it.
- Decided
- Nov 2, 1994
- Review
- 174 days
- Class
- Class II
- Product code
- KNS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K854238 (1985). 2 ancestors in all. 6 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK854238 Needle W/Stylet for ImplantationMicrovasive · 1985
- This deviceK942301 Microvasive Injection Gold ProbeBoston Scientific Corp · 1994
- Descendant · cites it directly · 5 of its ownK961349 Injection Gold ProbeBoston Scientific Corp · 1996
- Descendant · 2 generations on · 4 of its ownK110887 Injection Gold Probe Bipolar Electrohemostasis CatheterBoston Scientific Corporation · 2011
- Descendant · 3 generations on · 3 of its ownK133933 Injection Gold Probe Bipolar Electrohemostasis CatheterBoston Scientific Corporation · 2014
- Descendant · 4 generations on · 1 of its ownK171983 Creo Medical Electrosurgical System including Speedboat RS2 Surgical…Creo Medical, Ltd. · 2017
- Descendant · 4 generations on · 0 of its ownK232633 Gold Probe Bipolar Electrohemostasis Catheter; Injection Gold Probe…Boston Scientific · 2023
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K961349Injection Gold ProbeBoston Scientific Corp · 1996 · cites it directly5descendants
- K110887Injection Gold Probe Bipolar Electrohemostasis CatheterBoston Scientific Corporation · 2011 · 2 generations on4descendants
- K133933Injection Gold Probe Bipolar Electrohemostasis CatheterBoston Scientific Corporation · 2014 · 3 generations on3descendants
- K171983Creo Medical Electrosurgical System including Speedboat RS2 Surgical AccessoryCreo Medical, Ltd. · 2017 · 4 generations on1descendant
- K232633Gold Probe Bipolar Electrohemostasis Catheter; Injection Gold Probe Bipolar…Boston Scientific · 2023 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K854238 | Needle W/Stylet for Implantation | Microvasive | 1985 | — |
| 0 (this device) | K942301 | Microvasive Injection Gold Probe | Boston Scientific Corp | 1994 | — |
| +1 | K961349 | Injection Gold Probe | Boston Scientific Corp | 1996 | — |
| +2 | K110887 | Injection Gold Probe Bipolar Electrohemostasis Catheter | Boston Scientific Corporation | 2011 | — |
| +3 | K133933 | Injection Gold Probe Bipolar Electrohemostasis Catheter | Boston Scientific Corporation | 2014 | — |
| +4 | K171983 | Creo Medical Electrosurgical System including Speedboat RS2 Surgical Accessory | Creo Medical, Ltd. | 2017 | — |
| +4 | K232633 | Gold Probe Bipolar Electrohemostasis Catheter; Injection Gold Probe Bipolar… | Boston Scientific | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 2011 | 1 | 0 |
| 2014 | 1 | 0 |
| 2017 | 1 | 0 |
| 2020 | 1 | 0 |
| 2023 | 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 KNS? 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 KNS device
- #1 K241271 Aqua Medical RF Vapor Ablation Systemscore 17.2 · 20 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 |
|---|---|---|---|
| * | K885005 | Microvasive Gold ProbeSummary page 4…e Catheter Microvasive® Microvasive® o Varijject™ Clear Injection Injection Therapy Gold Probe™ Neeidle Catheter (Predicate Device) (Predicate Device) (Proposed Device) (K885005) . (K854238) . (This 510(k)_.. Used endoscopically to Endoscopic introduce a sclerosing Endoscopic injection Indications clectroh… | 1989 |
| * | K854238 | Needle W/Stylet for ImplantationSummary page 4…icrovasive® Microvasive® o Varijject™ Clear Injection Injection Therapy Gold Probe™ Neeidle Catheter (Predicate Device) (Predicate Device) (Proposed Device) (K885005) . (K854238) . (This 510(k)_.. Used endoscopically to Endoscopic introduce a sclerosing Endoscopic injection Indications clectrohemostasis of… | 1985 |
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K961349 | Injection Gold Probe | 1996 | 5 |
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?
- None of the 2 ancestors has a recall.
- Of its descendants, K961349 (Boston Scientific Corp, 1996) has gone furthest, with 5 descendants of its own.
How does its category compare?
All KNS devicesKNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KNS
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KNS
171in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KNS
14in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KNS
1,504in 2025
MAUDE reports naming product code KNS, 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 | 1 | — | 3 | 164 |
| 2008 | 3 | 61 | 5 | 587 |
| 2009 | 3 | 212 | 2 | 1,027 |
| 2010 | 4 | 168 | 0 | 908 |
| 2011 | 1 | — | 2 | 860 |
| 2012 | 2 | — | 0 | 848 |
| 2013 | 2 | — | 0 | 449 |
| 2014 | 1 | — | 0 | 405 |
| 2015 | 3 | 252 | 0 | 406 |
| 2016 | 3 | 30 | 6 | 457 |
| 2017 | 3 | 48 | 1 | 446 |
| 2018 | 5 | 62 | 0 | 563 |
| 2019 | 7 | 66 | 0 | 668 |
| 2020 | 4 | 212 | 0 | 906 |
| 2021 | 4 | 139 | 41 | 814 |
| 2022 | 3 | 182 | 0 | 913 |
| 2023 | 9 | 83 | 0 | 976 |
| 2024 | 3 | 198 | 14 | 1,533 |
| 2025 | 11 | 171 | 0 | 1,504 |
| 2026 | 2 | — | 4 | — |
What is it indicated for?
The Microvasive Injection Gold Probe is indicated for use in endoscopic injection therapy and electrohemostasis of actual or potential bleeding sites in the gastrointestinal tract, including, but not limited to: the esophagus, stomach, duodenum, and colon. These sites include the following: peptic ulcers; Mallory-Weiss tears; arteriovenous malformations (AVMs); Dieulafoy lesions; bleeding polyp stalks; and angiomata.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K942301 · printed Nov 6, 2026
Cite this page
510(k) Report. “K942301: Microvasive Injection Gold Probe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K942301
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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