510(k) · Cleared
ClearedMicrovasive 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 Apr 11, 1997 after a 78-day review. The FDA summary names its predicate without a number. 81 later devices descend from it.
- Decided
- Apr 11, 1997
- Review
- 78 days
- Class
- Class II
- Product code
- KNS
- Recalls
- None
- Predicates
- 0
81 later devices descend from it, 7 citing it directly.
- This deviceK970278 Microvasive Gold ProbeBoston Scientific Corp · 1997
- Descendant · cites it directly · 42 of its ownK023765 Stellartech Coagulation System (Models 1100C-115 & 1100C-230)Stellartech Research Corp. · 2002
- Descendant · cites it directly · 42 of its ownK013139 Stellartech Coagulation SystemStellartech Research Corp. · 2001
- Descendant · 2 generations on · 41 of its ownK032062 Stellartech Coagulation System, Models (1100C-115 & 1100C-230)Stellartech Research Corp. · 2003
- Descendant · 2 generations on · 39 of its ownK032452 Modification to: Stellartech Coagulation System, Models 1100C-115 &…Stellartech Research Corp. · 2003
- Descendant · 2 generations on · 38 of its ownK032721 Modification to: Stellartech Coagulation System (Models 1100C-115 &…Stellartech Research Corp. · 2003
Showing 5 of 81 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 81 · See all- K023765Stellartech Coagulation System (Models 1100C-115 & 1100C-230)Stellartech Research Corp. · 2002 · cites it directly42descendants
- K013139Stellartech Coagulation SystemStellartech Research Corp. · 2001 · cites it directly42descendants
- K032062Stellartech Coagulation System, Models (1100C-115 & 1100C-230)Stellartech Research Corp. · 2003 · 2 generations on41descendants
- K032452Modification to: Stellartech Coagulation System, Models 1100C-115 & 100C-230Stellartech Research Corp. · 2003 · 2 generations on39descendants
- K032721Modification to: Stellartech Coagulation System (Models 1100C-115 & 1100C-230)Stellartech Research Corp. · 2003 · 2 generations on38descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K970278 | Microvasive Gold Probe | Boston Scientific Corp | 1997 | — |
| +1 | K023765 | Stellartech Coagulation System (Models 1100C-115 & 1100C-230) | Stellartech Research Corp. | 2002 | — |
| +1 | K013139 | Stellartech Coagulation System | Stellartech Research Corp. | 2001 | — |
| +2 | K032062 | Stellartech Coagulation System, Models (1100C-115 & 1100C-230) | Stellartech Research Corp. | 2003 | — |
| +2 | K032452 | Modification to: Stellartech Coagulation System, Models 1100C-115 & 100C-230 | Stellartech Research Corp. | 2003 | — |
| +2 | K032721 | Modification to: Stellartech Coagulation System (Models 1100C-115 & 1100C-230) | Stellartech Research Corp. | 2003 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2002 | 2 | 0 |
| 2003 | 3 | 0 |
| 2004 | 3 | 0 |
| 2005 | 1 | 0 |
| 2006 | 5 | 0 |
| 2007 | 2 | 0 |
| 2008 | 2 | 0 |
| 2009 | 5 | 0 |
| 2010 | 4 | 0 |
| 2012 | 2 | 0 |
| 2013 | 2 | 0 |
| 2014 | 4 | 0 |
| 2015 | 5 | 0 |
| 2016 | 3 | 0 |
| 2017 | 6 | 0 |
| 2018 | 4 | 0 |
| 2019 | 6 | 0 |
| 2020 | 3 | 0 |
| 2021 | 5 | 0 |
| 2022 | 2 | 0 |
| 2023 | 4 | 0 |
| 2024 | 3 | 0 |
| 2025 | 2 | 0 |
| 2026 | 2 | 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 |
|---|---|---|---|
| * | — | Microvasive Gold Probe Named without a submission number | |
| * | — | ACMI Bicap Tumor Probe Named without a submission number |
What descends from it? (81)
See all 817 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K023765 | Stellartech Coagulation System (Models 1100C-115 & 1100C-230) | 2002 | 42 |
| K013139 | Stellartech Coagulation System | 2001 | 42 |
| K022595 | Wilson-Cook Cystotome | 2002 | 29 |
| K093008 | Halo Ablation Catheter, Model 90-9100 | 2010 | 14 |
| K072383 | Habib Endoblate | 2007 | 5 |
| K232633 | Gold Probe Bipolar Electrohemostasis Catheter; Injection Gold Probe Bipolar… | 2023 | 0 |
| K061544 | Stellartech 100 Coagulation System | 2006 | 0 |
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, K023765 (Stellartech Research Corp., 2002) has gone furthest, with 42 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 Gold Probe is indicated for use in transendoscopic electrocautery of visible bleeding and non-bleeding sites in the gastrointestinal tract including but not limited to, the esophagus, stomach, duodenum, and colon. The indications include peptic ulcers, Mallory-Weiss tears, arteriovenous malfunctions (AVMs), Dieulafoy lesions, bleeding polyp stocks, angiomata, Watermelon Stomach, Barrett’s Esophagus, angiodysplasia, and esophageal tumors.
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/K970278 · printed Nov 4, 2026
Cite this page
510(k) Report. “K970278: Microvasive Gold Probe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K970278
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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