510(k) · Cleared
ClearedMicroline Flexible Ligating Shears
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Microline Surgical, Inc. · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Mar 27, 2013 as substantially equivalent to K062257 (Starion Instruments, 2006) and 1 other predicate after an 89-day review. Its family tree reaches back 3 generations to 1990.
- Decided
- Mar 27, 2013
- Review
- 89 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K904578 (1990). 11 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK904578 Modification Auto Suture (R) Endoscopic ClampUnited States Surgical, A Division of Tyco Healthc · 1990
- 2 generations backK091869 Sils Clincher, Sils Dissector, Sils Grasper, Sils L-Hook, Sils ShearsCovidien Lp, Formerly Registered AS United States · 2009
- 1 generation backK122299 Spider Surgical Instruments, Flexible Monopolar Grasper Wavy…Transenterix, Inc. · 2012
- This deviceK124029 Microline Flexible Ligating ShearsMicroline Surgical, Inc. · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K904578 | Modification Auto Suture (R) Endoscopic Clamp | United States Surgical, A Division of Tyco Healthc | 1990 | — |
| −2 | K091869 | Sils Clincher, Sils Dissector, Sils Grasper, Sils L-Hook, Sils Shears | Covidien Lp, Formerly Registered AS United States | 2009 | — |
| −1 | K122299 | Spider Surgical Instruments, Flexible Monopolar Grasper Wavy Ratcheted, Spider… | Transenterix, Inc. | 2012 | — |
| 0 (this device) | K124029 | Microline Flexible Ligating Shears | Microline Surgical, Inc. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1992 | 2 | 0 |
| 1995 | 1 | 0 |
| 2000 | 1 | 0 |
| 2006 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 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? (2)
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 |
|---|---|---|---|
| * | K062257 | Starion Instruments Thermal Litigating ShearsSummary page 1…79 GEl Predicate Devices: This product is similar in design, composition, to and function to the: Thermal Ligating Shears (1K062257) cleared on October 10, 2006 and the Spider Flexible Monopolar Surgical Instruments (K122299) cle… | 2006 |
| * | K122299 | Spider Surgical Instruments, Flexible Monopolar Grasper Wavy Ratcheted, Spider Surgical…Summary page 1…Thermal Ligating Shears (1K062257) cleared on October 10, 2006 and the Spider Flexible Monopolar Surgical Instruments (K122299) cleared on October 25, 2012. Device Description and Technological Characteristics: The Microl… | 2012 |
What descends from it?
No later submission names this one as a predicate yet.
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 23 years and passes through 4 companies; a new generation was cleared every 3.1 years on median.
- 2 of the 11 ancestors have a recall of any class.
- 1 other device also cites its predicate K062257.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
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 Microline Flexible Ligating Shears are intended for simultaneous cutting and cauterization of soft tissue during minimally invasive abdominal laparoscopic surgery. The device may also be used for cutting natural, non-metallic sutures during surgery.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K124029 · printed Nov 6, 2026
Cite this page
510(k) Report. “K124029: Microline Flexible Ligating Shears.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K124029
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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