510(k) · Cleared
ClearedLigasure 5 MM Maryland Jaw Sealer/Divider One-Step Sealing (LF 17XX)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Covidien, Formerly Valleylab, A Division of Tyco H · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Dec 20, 2013 as substantially equivalent to K092879 (Valleylab, 2009) and 2 other predicates after a 51-day review. Its family tree reaches back 5 generations to 1994. 43 later devices descend from it.
- Decided
- Dec 20, 2013
- Review
- 51 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K932293 (1994). 13 ancestors in all. 43 later devices descend from it, 6 citing it directly.
- Root · 5 generations backK932293 Cabot Medical Bipolar Cutting ForcepsCabot Medical Corp. · 1994 · Recalled
- 4 generations backK981916 Ligasure Vessel Sealing SystemValleylab, Inc. · 1998
- 3 generations backK031011 Ligasure 5MM Laparoscopic Sealer-Divider, Model LS1500Valleylab, Inc. · 2003 · Recalled
- 2 generations backK102470 Lugasure Curved, Small Jaw, Open Sealer/DividerCovidien, Formerly Valleylab, · 2011
- 1 generation backK113572 Ligasure Curved, Small Jaw, Open Sealer/DividerCovidien, Formerly Valleylab, A Division of Tyco H · 2012
- This deviceK133338 Ligasure 5 MM Maryland Jaw Sealer/Divider One-Step Sealing (LF 17XX)Covidien, Formerly Valleylab, A Division of Tyco H · 2013
- Descendant · cites it directly · 40 of its ownK141153 Ligasure; Curved Small Jaw Sealer/Divider, 5MM Blunt Tip…Covidien · 2014
- Descendant · 2 generations on · 14 of its ownK152286 LigaSure Curved, Small Jaw, Open Sealer/DividerCovidien · 2015
- Descendant · cites it directly · 11 of its ownK170869 LigaSure Maryland Jaw Sealer/Divider One-step Sealing, Nano-coatedCovidien · 2017
- Descendant · 2 generations on · 6 of its ownK142929 Ligasure Blunt Tip Sealer/DividerCovidien · 2015
- Descendant · 3 generations on · 5 of its ownK173281 LigaSure Exact Dissector, Nano-coatedCovidien · 2018
Showing 5 of 43 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 43 · See all- K141153Ligasure; Curved Small Jaw Sealer/Divider, 5MM Blunt Tip Sealer/Divider, Maryland Jaw…Covidien · 2014 · cites it directly40descendants
- K152286LigaSure Curved, Small Jaw, Open Sealer/DividerCovidien · 2015 · 2 generations on14descendants
- K170869LigaSure Maryland Jaw Sealer/Divider One-step Sealing, Nano-coatedCovidien · 2017 · cites it directly11descendants
- K142929Ligasure Blunt Tip Sealer/DividerCovidien · 2015 · 2 generations on6descendants
- K173281LigaSure Exact Dissector, Nano-coatedCovidien · 2018 · 3 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K932293 | Cabot Medical Bipolar Cutting Forceps | Cabot Medical Corp. | 1994 | 3 |
| −4 | K981916 | Ligasure Vessel Sealing System | Valleylab, Inc. | 1998 | — |
| −3 | K031011 | Ligasure 5MM Laparoscopic Sealer-Divider, Model LS1500 | Valleylab, Inc. | 2003 | 2 |
| −2 | K102470 | Lugasure Curved, Small Jaw, Open Sealer/Divider | Covidien, Formerly Valleylab, | 2011 | — |
| −1 | K113572 | Ligasure Curved, Small Jaw, Open Sealer/Divider | Covidien, Formerly Valleylab, A Division of Tyco H | 2012 | — |
| 0 (this device) | K133338 | Ligasure 5 MM Maryland Jaw Sealer/Divider One-Step Sealing (LF 17XX) | Covidien, Formerly Valleylab, A Division of Tyco H | 2013 | — |
| +1 | K141153 | Ligasure; Curved Small Jaw Sealer/Divider, 5MM Blunt Tip Sealer/Divider… | Covidien | 2014 | — |
| +2 | K152286 | LigaSure Curved, Small Jaw, Open Sealer/Divider | Covidien | 2015 | — |
| +1 | K170869 | LigaSure Maryland Jaw Sealer/Divider One-step Sealing, Nano-coated | Covidien | 2017 | — |
| +2 | K142929 | Ligasure Blunt Tip Sealer/Divider | Covidien | 2015 | — |
| +3 | K173281 | LigaSure Exact Dissector, Nano-coated | Covidien | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 4 | 0 |
| 1996 | 1 | 0 |
| 2001 | 2 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 7 | 0 |
| 2017 | 4 | 0 |
| 2018 | 5 | 0 |
| 2020 | 2 | 0 |
| 2021 | 6 | 0 |
| 2022 | 3 | 0 |
| 2023 | 6 | 0 |
| 2024 | 2 | 0 |
| 2025 | 1 | 0 |
| 2026 | 4 | 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? (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 |
|---|---|---|---|
| * | K092879 | Ligasure 5MM Blunt Tip Laparoscopic Sealer-DividerSummary page 1…m. Laparoscopic. Sealer/Divider Device Common Name: Bipolar Electrosurgical Instrument Catalog Number: LF1537 5 10(k) Number: K092879 (cleared 10/16/2009) Manufacturer: Covidien Trade Name: LigaSureTM Curved. Small Jaw, Open… | 2009 |
| * | K102470 | Lugasure Curved, Small Jaw, Open Sealer/DividerSummary page 1…Small Jaw, Open Sealer/Divider Device Common Name: Bipolar Electrosurgical Instrument Catalog Number: LF12I2A 5 10(k) Numbers: K 102470 (cleared 2/7/2011), K 113572 (cleared 9/7/2012) Manufacturer: Covidien Device Description The LigaSureTm 5 mm M… | 2011 |
| * | K113572 | Ligasure Curved, Small Jaw, Open Sealer/DividerSummary page 1…r Device Common Name: Bipolar Electrosurgical Instrument Catalog Number: LF12I2A 5 10(k) Numbers: K 102470 (cleared 2/7/2011), K 113572 (cleared 9/7/2012) Manufacturer: Covidien Device Description The LigaSureTm 5 mm Maryland Jaw Sealer/Divider On… | 2012 |
What descends from it? (43)
See all 436 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K141153 | Ligasure; Curved Small Jaw Sealer/Divider, 5MM Blunt Tip Sealer/Divider, Maryland Jaw… | 2014 | 40 |
| K170869 | LigaSure Maryland Jaw Sealer/Divider One-step Sealing, Nano-coated | 2017 | 11 |
| K181085 | LigaSure Maryland Jaw Thoracic Sealer/Divider One-step Sealing, Nano-coated | 2018 | 1 |
| K180499 | Reprocessed LigaSure Maryland Jaw Sealer/Divider | 2018 | 0 |
| K161804 | LigaSure Retractable L-Hook Laparoscopic Sealer/Divider | 2016 | 0 |
| K152134 | Reprocessed Vessel Sealer | 2016 | 0 |
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 19 years and passes through 4 companies; a new generation was cleared every 4.1 years on median.
- 4 of the 13 ancestors have a recall of any class.
- Of its descendants, K141153 (Covidien, 2014) has gone furthest, with 40 descendants of its own.
- 4 other devices also cite its predicate K092879.
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 LigaSure"" 5 mm, Maryland Jaw, Open / Minimally Invasive Sealer/Dividers are bipolar electrosurgical instruments intended for use with the ForceTriadTh Energy Platform in general, minimally invasive and open surgical procedures where ligation and division of vessels and lymphatics is desired. The instrument creates a seal by application of RF electrosurgical energy to vascular structures (vessels and lymph) interposed between the jaws of the…
Read the full statement (166 words)
The LigaSure"" 5 mm, Maryland Jaw, Open / Minimally Invasive Sealer/Dividers are bipolar electrosurgical instruments intended for use with the ForceTriadTh Energy Platform in general, minimally invasive and open surgical procedures where ligation and division of vessels and lymphatics is desired. The instrument creates a seal by application of RF electrosurgical energy to vascular structures (vessels and lymph) interposed between the jaws of the instrument. A blade within the instrument is surgeon actuated to divide tissue.
Indications for use include general open and minimally invasive procedures including urologic, vascular, thoracic and thoracoscopic. and gynecologic procedures where ligation and division of the vessels is performed. These procedures include: laparoscopically assisted vaginal hysterectomy, Nissen fundoplication, colectomy. adhesiolysis, oophorectomy, etc. The device has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures, and should not be used for these procedures.
The LigaSure 5 mm Maryland Jaw Sealer/Dividers can be used on vessels and lymphatics up to and including 7 mm, and tissue bundles.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133338 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133338: Ligasure 5 MM Maryland Jaw Sealer/Divider One-Step Sealing (LF 17XX).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133338
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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