510(k) · Cleared
ClearedCaiman Seal and Cut Technology
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aesculap, Inc. · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Apr 28, 2014 as substantially equivalent to K130596 (Aesculap, Inc., 2013) after a 26-day review. Its family tree reaches back 8 generations to 1994. 1 later device descends from it.
- Decided
- Apr 28, 2014
- Review
- 26 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K932293 (1994). 19 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 8 generations backK932293 Cabot Medical Bipolar Cutting ForcepsCabot Medical Corp. · 1994 · Recalled
- 7 generations backK981916 Ligasure Vessel Sealing SystemValleylab, Inc. · 1998
- 6 generations backK031011 Ligasure 5MM Laparoscopic Sealer-Divider, Model LS1500Valleylab, Inc. · 2003 · Recalled
- 5 generations backK041587 Ligasure Precise Model #LS1200/Ligasure 5MM Laparoscopic Sealer…Valleylab · 2004
- 4 generations backK081312 Aragon Oneshot SystemAragon Surgical, Inc. · 2008
- 3 generations backK090306 Aragon Surgical RF System L2 InstrumentAragon Surgical, Inc. · 2009
- 2 generations backK093075 Aragon Surgical RF System Teleo InstrumentAragon Surgical, Inc. · 2010 · Recalled
- 1 generation backK130596 Caiman Seal and Cut TechnologyAesculap, Inc. · 2013
- This deviceK140839 Caiman Seal and Cut TechnologyAesculap, Inc. · 2014
- Descendant · cites it directly · 0 of its ownK151858 Caiman Seal and Cut TechnologyAesculap, Inc. · 2015 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K151858Caiman Seal and Cut TechnologyAesculap, Inc. · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K932293 | Cabot Medical Bipolar Cutting Forceps | Cabot Medical Corp. | 1994 | 3 |
| −7 | K981916 | Ligasure Vessel Sealing System | Valleylab, Inc. | 1998 | — |
| −6 | K031011 | Ligasure 5MM Laparoscopic Sealer-Divider, Model LS1500 | Valleylab, Inc. | 2003 | 2 |
| −5 | K041587 | Ligasure Precise Model #LS1200/Ligasure 5MM Laparoscopic Sealer Divider Model… | Valleylab | 2004 | — |
| −4 | K081312 | Aragon Oneshot System | Aragon Surgical, Inc. | 2008 | — |
| −3 | K090306 | Aragon Surgical RF System L2 Instrument | Aragon Surgical, Inc. | 2009 | — |
| −2 | K093075 | Aragon Surgical RF System Teleo Instrument | Aragon Surgical, Inc. | 2010 | 2 |
| −1 | K130596 | Caiman Seal and Cut Technology | Aesculap, Inc. | 2013 | — |
| 0 (this device) | K140839 | Caiman Seal and Cut Technology | Aesculap, Inc. | 2014 | — |
| +1 | K151858 | Caiman Seal and Cut Technology | Aesculap, Inc. | 2015 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 4 | 0 |
| 1996 | 1 | 0 |
| 2001 | 2 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 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 |
|---|---|---|---|
| * | K130596 | Caiman Seal and Cut TechnologySummary page 1…4400 PRODUCT CODE: GEl SUBSTANTIAL EQUIVALENCE Caiman Seal and Cut Technology is substantially equivalent to Caiman Seal and Cut Technology cleared via K 130596. DEVICE DESCRIPTION Caiman Seal and Cut Technology consists of the Lektrafuse RF Generator and the sterile, single use Caiman de… | 2013 |
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 |
|---|---|---|---|
| K151858 | Caiman Seal and Cut Technology | 2015 | 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 20 years and passes through 5 companies; a new generation was cleared every 3.2 years on median.
- 5 of the 19 ancestors have a recall of any class.
- Of its descendants, K151858 (Aesculap, Inc., 2015) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K130596.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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?
Caiman Seal and Cut Technology consists of dedicated bipolar electrosurgical instruments intended for use in general surgery and gynecologic surgical procedures where ligation and division of vessels is desired. The instruments create a seal by the application of bipolar clectrosurgicall RE energy (coagulation) to vascular structure (vessels) interposed between thejaws of te device. A cutting blade is actuated for the division of tissue. The Caimnan 12…
Read the full statement (196 words)
Caiman Seal and Cut Technology consists of dedicated bipolar electrosurgical instruments intended for use in general surgery and gynecologic surgical procedures where ligation and division of vessels is desired. The instruments create a seal by the application of bipolar clectrosurgicall RE energy (coagulation) to vascular structure (vessels) interposed between thejaws of te device. A cutting blade is actuated for the division of tissue.
The Caimnan 12 Plus (44cm) and the Caiman 5 are indicated for laparoscopic procedures and the Cainman 12 Plus (24cm) is indicated for open procedures. The indications for use include general surgical procedures, (including urologic, vascular, thoracic, and thoracoscopic), and gynecological procedures where ligation and division of vessels is performed. These procedures include: vaginal hysterectomies, Nissen fuandoplication, colectomy, adhesiolysis, bowel resection, and oophorectomny etc., or any procedure where vessel ligation (seal and cut), tissue grasping, and dissection is performed. The devices can be used on vessels up to and including 7mm and bundles as large as will fit in the jaws of the instrument.
Caiman Seal and Cut Technology has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures. Do not use the system for these procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140839 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140839: Caiman Seal and Cut Technology.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140839
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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