510(k) · Cleared
ClearedInjection Gold Probe Bipolar Electrohemostasis Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific Corporation · KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
Cleared on Apr 2, 2014 as substantially equivalent to K110887 (Boston Scientific Corporation, 2011) after a 100-day review. Its family tree reaches back 4 generations to 1985. 3 later devices descend from it.
- Decided
- Apr 2, 2014
- Review
- 100 days
- Class
- Class II
- Product code
- KNS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K854238 (1985). 5 ancestors in all. 3 later devices descend from it, 3 citing it directly.
- Root · 4 generations backK854238 Needle W/Stylet for ImplantationMicrovasive · 1985
- 3 generations backK942301 Microvasive Injection Gold ProbeBoston Scientific Corp · 1994
- 2 generations backK961349 Injection Gold ProbeBoston Scientific Corp · 1996
- 1 generation backK110887 Injection Gold Probe Bipolar Electrohemostasis CatheterBoston Scientific Corporation · 2011
- This deviceK133933 Injection Gold Probe Bipolar Electrohemostasis CatheterBoston Scientific Corporation · 2014
- Descendant · cites it directly · 1 of its ownK171983 Creo Medical Electrosurgical System including Speedboat RS2 Surgical…Creo Medical, Ltd. · 2017
- Descendant · cites it directly · 0 of its ownK232633 Gold Probe Bipolar Electrohemostasis Catheter; Injection Gold Probe…Boston Scientific · 2023
- Descendant · cites it directly · 0 of its ownK192905 Creo Electrosurgical System with HS1 Hemostasis AccessoryCreo Medical, Ltd. · 2020
Most influential descendants
Showing 3 of 3 · See all- K171983Creo Medical Electrosurgical System including Speedboat RS2 Surgical AccessoryCreo Medical, Ltd. · 2017 · cites it directly1descendant
- K232633Gold Probe Bipolar Electrohemostasis Catheter; Injection Gold Probe Bipolar…Boston Scientific · 2023 · cites it directly0descendants
- K192905Creo Electrosurgical System with HS1 Hemostasis AccessoryCreo Medical, Ltd. · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K854238 | Needle W/Stylet for Implantation | Microvasive | 1985 | — |
| −3 | K942301 | Microvasive Injection Gold Probe | Boston Scientific Corp | 1994 | — |
| −2 | K961349 | Injection Gold Probe | Boston Scientific Corp | 1996 | — |
| −1 | K110887 | Injection Gold Probe Bipolar Electrohemostasis Catheter | Boston Scientific Corporation | 2011 | — |
| 0 (this device) | K133933 | Injection Gold Probe Bipolar Electrohemostasis Catheter | Boston Scientific Corporation | 2014 | — |
| +1 | K171983 | Creo Medical Electrosurgical System including Speedboat RS2 Surgical Accessory | Creo Medical, Ltd. | 2017 | — |
| +1 | K232633 | Gold Probe Bipolar Electrohemostasis Catheter; Injection Gold Probe Bipolar… | Boston Scientific | 2023 | — |
| +1 | K192905 | Creo Electrosurgical System with HS1 Hemostasis Accessory | Creo Medical, Ltd. | 2020 | — |
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 |
|---|---|---|
| 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? (1)
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 |
|---|---|---|---|
| * | K110887 | Injection Gold Probe Bipolar Electrohemostasis CatheterSummary page 1…Predicate Device: Tradle Name: Injection Gold lProbeTM" Bipolar Electrohemostasis Cathecter Maiuacturer and Clearance Number Boston Scientific Corporation, K 110887 Classification Namec: Unit, llctrosurgical, lEndoseopic (with accessories) Regulation Number: 876.4300 Produ… | 2011 |
What descends from it? (3)
3 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?
- The line of descent spans 29 years and passes through 3 companies; a new generation was cleared every 9.0 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K171983 (Creo Medical, Ltd., 2017) has gone furthest, with 1 descendant 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. 2014, this device’s year, is highlighted.
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 Injection Gold Probe™ Bipolar Electrohemostasis Catheter is indicated for use in endoscopic injection therapy (to deliver pharmacological injection agents, such as vasoconstrictors) and endoscopic electrohemostasis (cauterization of tissue and coagulation of blood) of actual or potential bleeding sites in the gastrointestinal tract. These sites include the following:
Peptic Ulcers
Dieulafoy Lesions
Mallory-Weiss Tears
Bleeding Polyp Stalks
Arteriovenous Malformations (AVMs)
Angiomata
The Injection Gold Probe Bipolar Electrohemostasis Catheter also has irrigation capability. Any other use is not recommended.
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/K133933 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133933: Injection Gold Probe Bipolar Electrohemostasis Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133933
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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