510(k) · Cleared
ClearedGyrus Acmi Biocoag Probe
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Gyrus Acmi, Inc. · KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
Cleared on Oct 20, 2010 as substantially equivalent to K912129 (Biosearch Medical Products, Inc., 1991) and 2 other predicates after a 425-day review. Its family tree reaches back 1 generation to 1989. 2 later devices descend from it.
- Decided
- Oct 20, 2010
- Review
- 425 days
- Class
- Class II
- Product code
- KNS
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K892895 (1989). 3 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK892895 Model 8800 Bipolar Coagulation Therapeutic SystemEverest Medical Corp. · 1989
- This deviceK092571 Gyrus Acmi Biocoag ProbeGyrus Acmi, Inc. · 2010
- Descendant · cites it directly · 1 of its ownK123319 Gyrus Acmi Bicoag Hemostasis ProbeOlympus Surgical Technologies America · 2012 · Recalled
- Descendant · 2 generations on · 0 of its ownK232633 Gold Probe Bipolar Electrohemostasis Catheter; Injection Gold Probe…Boston Scientific · 2023
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 |
|---|---|---|---|---|---|
| −1 | K892895 | Model 8800 Bipolar Coagulation Therapeutic System | Everest Medical Corp. | 1989 | — |
| 0 (this device) | K092571 | Gyrus Acmi Biocoag Probe | Gyrus Acmi, Inc. | 2010 | — |
| +1 | K123319 | Gyrus Acmi Bicoag Hemostasis Probe | Olympus Surgical Technologies America | 2012 | 5 |
| +2 | 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 |
|---|---|---|
| 1991 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 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? (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 |
|---|---|---|---|
| * | K912129 | Dobbhoff (R) Bipolar Hemostatic ProbeSummary page 1…Hlemostasis Probe Generic/Common Name: Endoscopic electrosurgical accessories. Predicate Device Biosearch Hemostatic probe cleared under K9 12129 Everest Hemostatic Bipolar Probe cleared under K892895 Bard Biprobe cleared under K912601 Intended Uses The Gymus ACM! Inc. Bi… | 1991 |
| * | K892895 | Model 8800 Bipolar Coagulation Therapeutic SystemSummary page 1…Endoscopic electrosurgical accessories. Predicate Device Biosearch Hemostatic probe cleared under K9 12129 Everest Hemostatic Bipolar Probe cleared under K892895 Bard Biprobe cleared under K912601 Intended Uses The Gymus ACM! Inc. BiCoag Hemostasis Probe is intended for coagulation of act… | 1989 |
| * | K912601 | Biprobe (TM)Summary page 1…gical accessories. Predicate Device Biosearch Hemostatic probe cleared under K9 12129 Everest Hemostatic Bipolar Probe cleared under K892895 Bard Biprobe cleared under K912601 Intended Uses The Gymus ACM! Inc. BiCoag Hemostasis Probe is intended for coagulation of active bleeding lesions in the upper o… | 1991 |
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 |
|---|---|---|---|
| K123319 | Gyrus Acmi Bicoag Hemostasis Probe | 2012 | 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?
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. 2010, 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 Gyrus ACMI Inc. BiCoag Hemostasis Probe is intended for coagulation of active bleeding lesions in the upper or lower gastrointestinal tract during endoscopic procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092571 · printed Nov 6, 2026
Cite this page
510(k) Report. “K092571: Gyrus Acmi Biocoag Probe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K092571
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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