510(k) · Cleared
Recalled · 2010Hemostatix, Model 2400Z Thermal Scalpel System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Gyrus Ent LLC · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Feb 5, 2004 after a 129-day review. The FDA summary names its predicate without a number. 9 later devices descend from it. It has been recalled 2 times.
- Decided
- Feb 5, 2004
- Review
- 129 days
- Class
- Class II
- Product code
- GEI
- Recalls
- 2
- Predicates
- 0
9 later devices descend from it, 1 citing it directly.
- This deviceK033089 Hemostatix, Model 2400Z Thermal Scalpel SystemGyrus Ent LLC · 2004
- Descendant · cites it directly · 8 of its ownK091107 Model P8400 Hemostatix Thermal Scalpel SystemHemostatix Medical Technologies, LLC · 2009 · Recalled
- Descendant · 2 generations on · 5 of its ownK110439 Domain Surgical SystemDomain Surgical, Inc. · 2011
- Descendant · 3 generations on · 4 of its ownK121881 Domain Surgical SystemDomain Surgical, Inc. · 2012
- Descendant · 4 generations on · 3 of its ownK130606 Fmwand Ferromagnetic Surgical SystemDomain Surgical, Inc. · 2014
- Descendant · 5 generations on · 1 of its ownK141484 Open FmsealerDomain Surgical, Inc. · 2014 · Recalled
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K091107Model P8400 Hemostatix Thermal Scalpel SystemHemostatix Medical Technologies, LLC · 2009 · cites it directly8descendants
- K110439Domain Surgical SystemDomain Surgical, Inc. · 2011 · 2 generations on5descendants
- K121881Domain Surgical SystemDomain Surgical, Inc. · 2012 · 3 generations on4descendants
- K130606Fmwand Ferromagnetic Surgical SystemDomain Surgical, Inc. · 2014 · 4 generations on3descendants
- K141484Open FmsealerDomain Surgical, Inc. · 2014 · 5 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K033089 | Hemostatix, Model 2400Z Thermal Scalpel System | Gyrus Ent LLC | 2004 | — |
| +1 | K091107 | Model P8400 Hemostatix Thermal Scalpel System | Hemostatix Medical Technologies, LLC | 2009 | 2 |
| +2 | K110439 | Domain Surgical System | Domain Surgical, Inc. | 2011 | — |
| +3 | K121881 | Domain Surgical System | Domain Surgical, Inc. | 2012 | — |
| +4 | K130606 | Fmwand Ferromagnetic Surgical System | Domain Surgical, Inc. | 2014 | — |
| +5 | K141484 | Open Fmsealer | Domain Surgical, Inc. | 2014 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 3 | 0 |
| 2015 | 1 | 0 |
| 2018 | 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 GEI? 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 GEI device
- #1 K231790 The InMode System with the Morpheus8 Applicatorsscore 32.7 · 21 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 |
|---|---|---|---|
| * | — | Oximetrix Shaw Hemostatic Surgical System Named without a submission number |
What descends from it? (9)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K091107 | Model P8400 Hemostatix Thermal Scalpel System | 2009 | 8 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 27, 2010 | Not classified | Z-2595-2010 | Other | Lack of sterility assurance |
| Jul 27, 2010 | Not classified | Z-2596-2010 | Other | Lack of sterility assurance |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K091107 (Hemostatix Medical Technologies, LLC, 2009) has gone furthest, with 8 descendants of its own.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GEI
52in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GEI
113in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GEI
4in 2025
Class I (14 since 2007) Class II/III not classified
Adverse event reports per year · GEI
7,592in 2025
MAUDE reports naming product code GEI, 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 | 50 | 51 | 21 | 2,795 |
| 2008 | 61 | 71 | 19 | 2,556 |
| 2009 | 42 | 130 | 27 | 3,591 |
| 2010 | 46 | 109 | 51 | 3,377 |
| 2011 | 35 | 135 | 32 | 4,463 |
| 2012 | 39 | 133 | 30 | 5,216 |
| 2013 | 48 | 136 | 13 | 4,897 |
| 2014 | 49 | 103 | 3 | 4,908 |
| 2015 | 47 | 123 | 4 | 4,936 |
| 2016 | 64 | 108 | 3 | 5,616 |
| 2017 | 52 | 72 | 2 | 6,073 |
| 2018 | 47 | 93 | 6 | 6,545 |
| 2019 | 48 | 93 | 5 | 7,067 |
| 2020 | 59 | 105 | 1 | 6,490 |
| 2021 | 46 | 146 | 6 | 6,354 |
| 2022 | 55 | 150 | 49 | 6,103 |
| 2023 | 65 | 104 | 27 (4) | 7,176 |
| 2024 | 59 | 125 | 22 (10) | 7,897 |
| 2025 | 52 | 113 | 4 | 7,592 |
| 2026 | 43 | 183 | 8 | — |
What is it indicated for?
The Hemostatix Model 2400Z Scalpel System is a surgical instrument designed to
retain the precise, clean cutting characteristics of the traditional steel scalpel and to
minimize blood loss by simultaneously sealing blood vessels as they are cut, with
minimum tissue damage and virtually no muscle stimulation, using heat thermally
conducted to the tissue from an elevated-temperature blade.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033089 · printed Nov 4, 2026
Cite this page
510(k) Report. “K033089: Hemostatix, Model 2400Z Thermal Scalpel System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K033089
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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