510(k) · Cleared
Recalled · 2005Tissuelink Solid Cylinder Monopolar Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tissuelink Medical, Inc. · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Mar 27, 2002 after a 90-day review. The FDA summary names its predicate without a number. 9 later devices descend from it. It has been recalled once.
- Decided
- Mar 27, 2002
- Review
- 90 days
- Class
- Class II
- Product code
- GEI
- Recalls
- 1
- Predicates
- 0
9 later devices descend from it, 2 citing it directly.
- This deviceK014260 Tissuelink Solid Cylinder Monopolar DeviceTissuelink Medical, Inc. · 2002
- Descendant · cites it directly · 4 of its ownK082568 Saline Enhanced Electrosurgical Resection (Seer) DeviceBovie Medical · 2008
- Descendant · cites it directly · 3 of its ownK101057 Aquamantys Double Cone Bipolar Sealer Model: 23-310-1Salient Surgical Technologies · 2011
- Descendant · 2 generations on · 2 of its ownK121678 DTADGyrus Acmi, Inc. · 2012
- Descendant · 3 generations on · 1 of its ownK123429 Olympus Energy Power System (Eps)Gyrus Acmi, Inc. · 2013 · Recalled
- Descendant · 2 generations on · 1 of its ownK120537 AQUAMANTYS3 9.5 XL Bipolar SealerMedtronic, Inc. · 2012
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K082568Saline Enhanced Electrosurgical Resection (Seer) DeviceBovie Medical · 2008 · cites it directly4descendants
- K101057Aquamantys Double Cone Bipolar Sealer Model: 23-310-1Salient Surgical Technologies · 2011 · cites it directly3descendants
- K121678DTADGyrus Acmi, Inc. · 2012 · 2 generations on2descendants
- K123429Olympus Energy Power System (Eps)Gyrus Acmi, Inc. · 2013 · 3 generations on1descendant
- K120537AQUAMANTYS3 9.5 XL Bipolar SealerMedtronic, Inc. · 2012 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K014260 | Tissuelink Solid Cylinder Monopolar Device | Tissuelink Medical, Inc. | 2002 | — |
| +1 | K082568 | Saline Enhanced Electrosurgical Resection (Seer) Device | Bovie Medical | 2008 | — |
| +1 | K101057 | Aquamantys Double Cone Bipolar Sealer Model: 23-310-1 | Salient Surgical Technologies | 2011 | — |
| +2 | K121678 | DTAD | Gyrus Acmi, Inc. | 2012 | — |
| +3 | K123429 | Olympus Energy Power System (Eps) | Gyrus Acmi, Inc. | 2013 | 12 |
| +2 | K120537 | AQUAMANTYS3 9.5 XL Bipolar Sealer | Medtronic, Inc. | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 2 | 0 |
| 2022 | 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 |
|---|---|---|---|
| * | — | TissueLink Monopolar Floating Ball Named without a submission number |
What descends from it? (9)
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 |
|---|---|---|---|---|
| Feb 7, 2005 | Not classified | Z-0563-05 | Other | The tip may separate from the device and render it unusable |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K082568 (Bovie Medical, 2008) has gone furthest, with 4 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?
The TissueLink Solid Cylinder monopolar device is a sterile, single use electrosurgery device intended to be used in conjunction with an electrosurgical generator for delivery of radiofrequency current and saline for blunt dissection, hemostatic sealing and coagulation of soft tissue at the operative site. It is intended for, but not limited to, endoscopic and open abdominal and thoracic surgery. The device is not intended for contraceptive tubal coagulation (permanent female sterilization).
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K014260 · printed Nov 6, 2026
Cite this page
510(k) Report. “K014260: Tissuelink Solid Cylinder Monopolar Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K014260
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026