510(k) · Cleared
ClearedCoolSeal Reveal
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bolder Surgical, LLC · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on May 6, 2021 as substantially equivalent to K173281 (Covidien, 2018) and 1 other predicate after a 143-day review. Its family tree reaches back 9 generations to 1994.
- Decided
- May 6, 2021
- Review
- 143 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 9 generations to K932293 (1994). 26 ancestors in all. No later device cites it as a predicate yet.
- Root · 9 generations backK932293 Cabot Medical Bipolar Cutting ForcepsCabot Medical Corp. · 1994 · Recalled
- 5 generations between
- 3 generations backK141153 Ligasure; Curved Small Jaw Sealer/Divider, 5MM Blunt Tip…Covidien · 2014
- 2 generations backK152286 LigaSure Curved, Small Jaw, Open Sealer/DividerCovidien · 2015
- 1 generation backK173281 LigaSure Exact Dissector, Nano-coatedCovidien · 2018
- This deviceK203640 CoolSeal RevealBolder Surgical, LLC · 2021
Show all 9 generations
- Root · 9 generations backK932293 Cabot Medical Bipolar Cutting ForcepsCabot Medical Corp. · 1994 · Recalled
- 8 generations backK981916 Ligasure Vessel Sealing SystemValleylab, Inc. · 1998
- 7 generations backK031011 Ligasure 5MM Laparoscopic Sealer-Divider, Model LS1500Valleylab, Inc. · 2003 · Recalled
- 6 generations backK102470 Lugasure Curved, Small Jaw, Open Sealer/DividerCovidien, Formerly Valleylab, · 2011
- 5 generations backK113572 Ligasure Curved, Small Jaw, Open Sealer/DividerCovidien, Formerly Valleylab, A Division of Tyco H · 2012
- 4 generations backK133338 Ligasure 5 MM Maryland Jaw Sealer/Divider One-Step Sealing (LF 17XX)Covidien, Formerly Valleylab, A Division of Tyco H · 2013
- 3 generations backK141153 Ligasure; Curved Small Jaw Sealer/Divider, 5MM Blunt Tip…Covidien · 2014
- 2 generations backK152286 LigaSure Curved, Small Jaw, Open Sealer/DividerCovidien · 2015
- 1 generation backK173281 LigaSure Exact Dissector, Nano-coatedCovidien · 2018
- This deviceK203640 CoolSeal RevealBolder Surgical, LLC · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K932293 | Cabot Medical Bipolar Cutting Forceps | Cabot Medical Corp. | 1994 | 3 |
| −8 | K981916 | Ligasure Vessel Sealing System | Valleylab, Inc. | 1998 | — |
| −7 | K031011 | Ligasure 5MM Laparoscopic Sealer-Divider, Model LS1500 | Valleylab, Inc. | 2003 | 2 |
| −6 | K102470 | Lugasure Curved, Small Jaw, Open Sealer/Divider | Covidien, Formerly Valleylab, | 2011 | — |
| −5 | K113572 | Ligasure Curved, Small Jaw, Open Sealer/Divider | Covidien, Formerly Valleylab, A Division of Tyco H | 2012 | — |
| −4 | K133338 | Ligasure 5 MM Maryland Jaw Sealer/Divider One-Step Sealing (LF 17XX) | Covidien, Formerly Valleylab, A Division of Tyco H | 2013 | — |
| −3 | 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 | K173281 | LigaSure Exact Dissector, Nano-coated | Covidien | 2018 | — |
| 0 (this device) | K203640 | CoolSeal Reveal | Bolder Surgical, LLC | 2021 | — |
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 | 3 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 3 | 0 |
| 2016 | 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 |
|---|---|---|---|
| * | K173281 | LigaSure Exact Dissector, Nano-coatedSummary page 4…II Produce Code: GEI PREDICATE DEVICES Trade Name: LigaSure Exact Dissector, Nano-Coated 510(k): K173281 Common or Usual Name: Bipolar Vessel Sealing System Classification Name: Electrosurgical cutting and coagu… | 2018 |
| * | K160602 | JustRight Surgical Vessel Sealing SystemSummary page 4…accessories Regulatory Class: II Produce Code: GEI Trade Name: JustRight™ Sealer 510(k) K160602 Common or Usual Name: Bipolar Vessel Sealing System Classification Name: Electrosurgical cutting and coagu… | 2016 |
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 27 years and passes through 6 companies; a new generation was cleared every 2.5 years on median.
- 6 of the 26 ancestors have a recall of any class.
- 2 other devices also cite its predicate K173281.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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 CoolSeal™ Reveal is a bipolar electrosurgical instrument intended for use in open surgical procedures in adults and pediatrics where ligation and division of vessels, tissue bundles, and lymphatics is desired. The CoolSeal™ Reveal can be be used on vessels (arteries and veins) up to and including 6 mm in diameter. It is indicated for use in general surgery and in such surgical specialties as urologic, thoracic, plastic, and reconstructive. Procedures…
Read the full statement (156 words)
The CoolSeal™ Reveal is a bipolar electrosurgical instrument intended for use in open surgical procedures in adults and
pediatrics where ligation and division of vessels, tissue bundles, and lymphatics is desired. The CoolSeal™ Reveal can be
be used on vessels (arteries and veins) up to and including 6 mm in diameter. It is indicated for use in general surgery and in
such surgical specialties as urologic, thoracic, plastic, and reconstructive. Procedures may include but are not limited to,
bowel resections, gall bladder procedures, Nissen fundoplication, and adhesiolysis.
The CoolSeal™ Reveal is also indicated for open ENT procedures in adults (thyroidectomy, radical neck dissection, and
parotidectomy) for ligation and division of vessels, lymphatics and tissue bundles 2-3 mm away from unintended
thermallysensitive structures such as nerves and parathyroid glands.
The CoolSeal™ Reveal has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization
procedures. Do not use the CoolSeal™ Reveal for these procedures.
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/K203640 · printed Nov 6, 2026
Cite this page
510(k) Report. “K203640: CoolSeal Reveal.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K203640
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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