510(k) · Cleared
Recalled · Class II · 2019Aragon Surgical RF System Teleo Instrument
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aragon Surgical, Inc. · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Jan 21, 2010 as substantially equivalent to K090306 (Aragon Surgical, Inc., 2009) after a 113-day review. Its family tree reaches back 6 generations to 1994. 7 later devices descend from it. It has been recalled 2 times.
- Decided
- Jan 21, 2010
- Review
- 113 days
- Class
- Class II
- Product code
- GEI
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 6 generations to K932293 (1994). 13 ancestors in all. 7 later devices descend from it, 1 citing it directly.
- Root · 6 generations backK932293 Cabot Medical Bipolar Cutting ForcepsCabot Medical Corp. · 1994 · Recalled
- 5 generations backK981916 Ligasure Vessel Sealing SystemValleylab, Inc. · 1998
- 4 generations backK031011 Ligasure 5MM Laparoscopic Sealer-Divider, Model LS1500Valleylab, Inc. · 2003 · Recalled
- 3 generations backK041587 Ligasure Precise Model #LS1200/Ligasure 5MM Laparoscopic Sealer…Valleylab · 2004
- 2 generations backK081312 Aragon Oneshot SystemAragon Surgical, Inc. · 2008
- 1 generation backK090306 Aragon Surgical RF System L2 InstrumentAragon Surgical, Inc. · 2009
- This deviceK093075 Aragon Surgical RF System Teleo InstrumentAragon Surgical, Inc. · 2010
- Descendant · cites it directly · 6 of its ownK130596 Caiman Seal and Cut TechnologyAesculap, Inc. · 2013
- Descendant · 2 generations on · 2 of its ownK151696 Caiman Seal and Cut TechnologyAesculap, Inc. · 2015
- Descendant · 2 generations on · 1 of its ownK140839 Caiman Seal and Cut TechnologyAesculap, Inc. · 2014
- Descendant · 2 generations on · 0 of its ownK203461 Aesculap Caiman 12 Seal and Cut Technology SystemAesculap, Inc. · 2020
- Descendant · 3 generations on · 0 of its ownK202938 Aesculap Caiman 5 Seal and Cut Technology SystemAesculap, Inc. · 2020
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K130596Caiman Seal and Cut TechnologyAesculap, Inc. · 2013 · cites it directly6descendants
- K151696Caiman Seal and Cut TechnologyAesculap, Inc. · 2015 · 2 generations on2descendants
- K140839Caiman Seal and Cut TechnologyAesculap, Inc. · 2014 · 2 generations on1descendant
- K203461Aesculap Caiman 12 Seal and Cut Technology SystemAesculap, Inc. · 2020 · 2 generations on0descendants
- K202938Aesculap Caiman 5 Seal and Cut Technology SystemAesculap, Inc. · 2020 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K932293 | Cabot Medical Bipolar Cutting Forceps | Cabot Medical Corp. | 1994 | 3 |
| −5 | K981916 | Ligasure Vessel Sealing System | Valleylab, Inc. | 1998 | — |
| −4 | K031011 | Ligasure 5MM Laparoscopic Sealer-Divider, Model LS1500 | Valleylab, Inc. | 2003 | 2 |
| −3 | K041587 | Ligasure Precise Model #LS1200/Ligasure 5MM Laparoscopic Sealer Divider Model… | Valleylab | 2004 | — |
| −2 | K081312 | Aragon Oneshot System | Aragon Surgical, Inc. | 2008 | — |
| −1 | K090306 | Aragon Surgical RF System L2 Instrument | Aragon Surgical, Inc. | 2009 | — |
| 0 (this device) | K093075 | Aragon Surgical RF System Teleo Instrument | Aragon Surgical, Inc. | 2010 | — |
| +1 | K130596 | Caiman Seal and Cut Technology | Aesculap, Inc. | 2013 | — |
| +2 | K151696 | Caiman Seal and Cut Technology | Aesculap, Inc. | 2015 | — |
| +2 | K140839 | Caiman Seal and Cut Technology | Aesculap, Inc. | 2014 | — |
| +2 | K203461 | Aesculap Caiman 12 Seal and Cut Technology System | Aesculap, Inc. | 2020 | — |
| +3 | K202938 | Aesculap Caiman 5 Seal and Cut Technology System | Aesculap, Inc. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 4 | 0 |
| 1996 | 1 | 0 |
| 2001 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 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 |
|---|---|---|---|
| * | K090306 | Aragon Surgical RF System L2 InstrumentSummary page 1…el: General Surgery/Restorative Devices Device Classification: Class II PREDICATE DEVICES Aragon Surgical RE Systerm/L2 Instrument (KO090306) DEVICE DESCRIPTION The Aragon Surgical, RF Systems consists of two components: the Aragon Surgical Generator and the Aragon Sur… | 2009 |
What descends from it? (7)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K130596 | Caiman Seal and Cut Technology | 2013 | 6 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 7, 2019 | Class II | Z-2496-2019 | Unknown/Undetermined by firm | possibility of the sterility batch being insufficiently sterilized |
| Aug 7, 2019 | Class II | Z-2497-2019 | Unknown/Undetermined by firm | possibility of the sterility batch being insufficiently sterilized |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 16 years and passes through 4 companies; a new generation was cleared every 4.1 years on median.
- 3 of the 13 ancestors have a recall of any class.
- Of its descendants, K130596 (Aesculap, Inc., 2013) has gone furthest, with 6 descendants of its own.
- 2 other devices also cite its predicate K090306.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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 Aragon Surgical Telco Instrument is a dedicated bipolar electrosurgical instrument intended for use in general surgical and gynecologic procedures where ligation and division of vessels is desired. The instrument creates a seal by the application of bipolar electrosurgical RF energy (coagulation) to vascular structure (vessels) interposed between the jaws of the device. A cutting blade is actuated for the division of tissue. The indications for use…
Read the full statement (172 words)
The Aragon Surgical Telco Instrument is a dedicated bipolar electrosurgical instrument intended for use in general surgical and gynecologic procedures where ligation and division of vessels is desired. The instrument creates a seal by the application of bipolar electrosurgical RF energy (coagulation) to vascular structure (vessels) interposed between the jaws of the device. A cutting blade is actuated for the division of tissue.
The indications for use include general surgical procedures (including urologic, vascular, thoracic, and thoracoscopic), and gynecologic surgery procedures where ligation and division of vessels is performed. These procedures include: vaginal hysterectomies, Nissen fundoplication, colectomy, adhesiolysis, bowel resections and oophorectomy etc., or any procedure where vessel ligation (cutting and sealing), tissue grasping, and dissection is performed.
The device can be used on vessels up to and including 7mm and bundles as large as will fit in the jaws of the instrument.
The Aragon Surgical Telco Instrument 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/K093075 · printed Nov 6, 2026
Cite this page
510(k) Report. “K093075: Aragon Surgical RF System Teleo Instrument.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K093075
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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