510(k) · Cleared
Recalled · Class II · 2026Gyrus Acmi Bicoag Hemostasis Probe
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Olympus Surgical Technologies America · KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
Cleared on Dec 14, 2012 as substantially equivalent to K092571 (Gyrus Acmi, Inc., 2010) after a 49-day review. Its family tree reaches back 2 generations to 1989. 1 later device descends from it. It has been recalled 5 times.
- Decided
- Dec 14, 2012
- Review
- 49 days
- Class
- Class II
- Product code
- KNS
- Recalls
- 5
- Predicates
- 1
Its longest line of descent runs back 2 generations to K892895 (1989). 4 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK892895 Model 8800 Bipolar Coagulation Therapeutic SystemEverest Medical Corp. · 1989
- 1 generation backK092571 Gyrus Acmi Biocoag ProbeGyrus Acmi, Inc. · 2010
- This deviceK123319 Gyrus Acmi Bicoag Hemostasis ProbeOlympus Surgical Technologies America · 2012
- Descendant · cites it directly · 0 of its ownK232633 Gold Probe Bipolar Electrohemostasis Catheter; Injection Gold Probe…Boston Scientific · 2023
Most influential descendants
Showing 1 of 1 · See all- K232633Gold Probe Bipolar Electrohemostasis Catheter; Injection Gold Probe Bipolar…Boston Scientific · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K892895 | Model 8800 Bipolar Coagulation Therapeutic System | Everest Medical Corp. | 1989 | — |
| −1 | K092571 | Gyrus Acmi Biocoag Probe | Gyrus Acmi, Inc. | 2010 | — |
| 0 (this device) | K123319 | Gyrus Acmi Bicoag Hemostasis Probe | Olympus Surgical Technologies America | 2012 | — |
| +1 | 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 |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K092571 | Gyrus Acmi Biocoag ProbeSummary page 1…BiCOAG Hemostasis Probe Generic/Common Name: BiCOAG, BiCOAG Probe Predicate Device Gyrus AGMI BiCOAG Hemostasis Probe K092571 Indications for Use The G yrus ACMI BiCOAG Hemostasis Probe is intended for coagulation of active bleeding lesions in the upper… | 2010 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K232633 | Gold Probe Bipolar Electrohemostasis Catheter; Injection Gold Probe Bipolar… | 2023 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 19, 2026 | Class II | Z-3245-2026 | Nonconforming Material/Component | Potential for detachment of ceramic tip due to manufacturing without the designated amount of adhesive. |
| Aug 19, 2026 | Class II | Z-3247-2026 | Nonconforming Material/Component | Potential for detachment of ceramic tip due to manufacturing without the designated amount of adhesive. |
| Aug 19, 2026 | Class II | Z-3244-2026 | Nonconforming Material/Component | Potential for detachment of ceramic tip due to manufacturing without the designated amount of adhesive. |
| Aug 19, 2026 | Class II | Z-3246-2026 | Nonconforming Material/Component | Potential for detachment of ceramic tip due to manufacturing without the designated amount of adhesive. |
| Jan 5, 2024 | Class II | Z-1481-2024 | Employee error | The BICOAG Hemostasis Probe with a coaxial plug was mispackaged into the package and labeled as a BICOAG Hemostasis Probe with a fixed pin connector. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 23 years and passes through 3 companies; a new generation was cleared every 21.1 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K232633 (Boston Scientific, 2023) has gone furthest, with 0 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. 2012, 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 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/K123319 · printed Nov 6, 2026
Cite this page
510(k) Report. “K123319: Gyrus Acmi Bicoag Hemostasis Probe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K123319
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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