510(k) · Cleared
Recalled · Class II · 2019Starion Instruments Thermal Litigating Shears
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Starion Instruments · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Oct 10, 2006 as substantially equivalent to K002547 (Starion Instruments, 2000) after a 67-day review. Its family tree reaches back 1 generation to 2000. 2 later devices descend from it. It has been recalled 3 times.
- Decided
- Oct 10, 2006
- Review
- 67 days
- Class
- Class II
- Product code
- GEI
- Recalls
- 3
- Predicates
- 1
Its longest line of descent runs back 1 generation to K002547 (2000). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK002547 Starion Instruments Power Point Cautery Grasper/DissectorStarion Instruments · 2000
- This deviceK062257 Starion Instruments Thermal Litigating ShearsStarion Instruments · 2006
- Descendant · cites it directly · 0 of its ownK124029 Microline Flexible Ligating ShearsMicroline Surgical, Inc. · 2013
- Descendant · cites it directly · 0 of its ownK122086 Thermal Ligating ShearsMicroline Surgical, Inc. · 2012
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 | K002547 | Starion Instruments Power Point Cautery Grasper/Dissector | Starion Instruments | 2000 | — |
| 0 (this device) | K062257 | Starion Instruments Thermal Litigating Shears | Starion Instruments | 2006 | — |
| +1 | K124029 | Microline Flexible Ligating Shears | Microline Surgical, Inc. | 2013 | — |
| +1 | K122086 | Thermal Ligating Shears | Microline Surgical, Inc. | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 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 |
|---|---|---|---|
| * | K002547 | Starion Instruments Power Point Cautery Grasper/DissectorSummary page 1…rinciples of operation to the Starion Instruments Thermal Cautery Grasper/Dissector, a legally marketable predicate device which has been granted marketing clearance via K002547. The Starion Instruments Thermal Ligating Shears allow the surgeon to position the distal jaws of the instrument around t… | 2000 |
What descends from it? (2)
2 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 22, 2019 | Class II | Z-1698-2019 | Under Investigation by firm | The shears exhibited a high rate of complete or intermittent failure to actuate. As a result, they do not perform their intended function in surgical procedures. |
| Mar 9, 2010 | Not classified | Z-2239-2010 | Device Design | The Starion Instruments Thermal Ligating Shears (STLS) 35C and the Starion Thermal Ligating Shears (STLS) 23C may turn on and remain on without the finger button being depressed. The devices may also work intermittently, incorrectly… |
| Jun 26, 2008 | Not classified | Z-1972-2010 | Process control | Due to an improper fixture revision, device may be missing a screw at the jaw assembly, resulting in jaw components falling off during use. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- Of its descendants, K124029 (Microline Surgical, Inc., 2013) has gone furthest, with 0 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?
For the simultaneous cutting and cauterization of soft tissue during surgery.
Cutting of natural or synthetic, non-metallic, sutures during surgery.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062257 · printed Nov 5, 2026
Cite this page
510(k) Report. “K062257: Starion Instruments Thermal Litigating Shears.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K062257
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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