510(k) Report

510(k) · Cleared

Cleared

JustRight Surgical Vessel Sealing System

K160602510(k) TraditionalCleared Jun 23, 2016113-day reviewClass II21 CFR 878.4400

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Justright Surgical · GEI Electrosurgical, Cutting & Coagulation & Accessories

Cleared on Jun 23, 2016 as substantially equivalent to K123662 (Justright Surgical, LLC, 2013) and 2 other predicates after a 113-day review. Its family tree reaches back 5 generations to 1994. 6 later devices descend from it.

Decided
Jun 23, 2016
Review
113 days
Class
Class II
Product code
GEI
Recalls
None
Predicates
3

Its longest line of descent runs back 5 generations to K932293 (1994). 10 ancestors in all. 6 later devices descend from it, 3 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1996: 1 other ancestor1995: 4 other ancestors2021: 3 descendants cleared2020: 1 descendant cleared2026: 1 descendant cleared2023: 1 descendant clearedK932293 · Cabot Medical Bipolar Cutting Forceps · Cabot Medical Corp. · 1994 · recalledK981916 · Ligasure Vessel Sealing System · Valleylab, Inc. · 1998K051644 · Valleylab Forcetriad Electrosurgical Generator · Valleylab · 2005K070162 · Forcetriad Electrosurgical Generator; Ligasure Instruments · Valleylab,A Division of Tyco Healthcare Group LP · 2007K123662 · The Justright Surgical Vessel Sealing System · Justright Surgical, LLC · 20131990200020102020
Other ancestors, by generationDescendants, by generation 2 generations back: 5 other ancestors 1 generation forward: 3 descendants2 generations forward: 2 descendants3 generations forward: 1 descendant K123662 · The Justright Surgical Vessel Sealing System · Justright Surgical, LLC · 2013K070162 · Forcetriad Electrosurgical Generator; Ligasure Instruments · Valleylab,A Division of Tyco Healthcare Group LP · 2007K051644 · Valleylab Forcetriad Electrosurgical Generator · Valleylab · 2005K981916 · Ligasure Vessel Sealing System · Valleylab, Inc. · 1998K932293 · Cabot Medical Bipolar Cutting Forceps · Cabot Medical Corp. · 1994 · recalled−50
  1. Root · 5 generations backK932293 Cabot Medical Bipolar Cutting ForcepsCabot Medical Corp. · 1994 · Recalled
  2. 4 generations backK981916 Ligasure Vessel Sealing SystemValleylab, Inc. · 1998
  3. 3 generations backK051644 Valleylab Forcetriad Electrosurgical GeneratorValleylab · 2005
  4. 2 generations backK070162 Forcetriad Electrosurgical Generator; Ligasure InstrumentsValleylab,A Division of Tyco Healthcare Group LP · 2007
  5. 1 generation backK123662 The Justright Surgical Vessel Sealing SystemJustright Surgical, LLC · 2013
  6. This deviceK160602 JustRight Surgical Vessel Sealing SystemJustright Surgical · 2016
  7. Descendant · cites it directly · 4 of its ownK202114 CoolSeal Generator/CSL-200-50, CoolSeal Trinity (30 cm…Bolder Surgical, LLC · 2020 · Recalled
  8. Descendant · cites it directly · 2 of its ownK203183 CoolSeal Trinity (30 cm shaft, 37 cm shaft, and 44 cm shaft)Bolder Surgical, LLC · 2021
  9. Descendant · 2 generations on · 1 of its ownK211579 CoolSeal Trinity (30 cm shaft), CoolSeal Trinity (37 cm shaft)…Bolder Surgical, LLC · 2021
  10. Descendant · 2 generations on · 0 of its ownK253634 CoolSeal Generator® (CSL-200-90)Hologic, Inc. · 2026
  11. Descendant · 3 generations on · 0 of its ownK231012 CoolSeal TrinityBolder Surgical, LLC · 2023

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2020: 12021: 32023: 12026: 1
2020high 3 (2021) · low 0 (2022)2026

Most influential descendants

Showing 5 of 6 · See all
  • K202114CoolSeal Generator/CSL-200-50, CoolSeal Trinity (30 cm shaft)/CSL-TR105-30, CoolSeal…Bolder Surgical, LLC · 2020 · cites it directly4descendants
  • K203183CoolSeal Trinity (30 cm shaft, 37 cm shaft, and 44 cm shaft)Bolder Surgical, LLC · 2021 · cites it directly2descendants
  • K211579CoolSeal Trinity (30 cm shaft), CoolSeal Trinity (37 cm shaft), CoolSeal Trinity (44 cm…Bolder Surgical, LLC · 2021 · 2 generations on1descendant
  • K253634CoolSeal Generator® (CSL-200-90)Hologic, Inc. · 2026 · 2 generations on0descendants
  • K231012CoolSeal TrinityBolder Surgical, LLC · 2023 · 3 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−5K932293Cabot Medical Bipolar Cutting ForcepsCabot Medical Corp.19943
−4K981916Ligasure Vessel Sealing SystemValleylab, Inc.1998—
−3K051644Valleylab Forcetriad Electrosurgical GeneratorValleylab2005—
−2K070162Forcetriad Electrosurgical Generator; Ligasure InstrumentsValleylab,A Division of Tyco Healthcare Group LP2007—
−1K123662The Justright Surgical Vessel Sealing SystemJustright Surgical, LLC2013—
0 (this device)K160602JustRight Surgical Vessel Sealing SystemJustright Surgical2016—
+1K202114CoolSeal Generator/CSL-200-50, CoolSeal Trinity (30 cm shaft)/CSL-TR105-30…Bolder Surgical, LLC20201
+1K203183CoolSeal Trinity (30 cm shaft, 37 cm shaft, and 44 cm shaft)Bolder Surgical, LLC2021—
+2K211579CoolSeal Trinity (30 cm shaft), CoolSeal Trinity (37 cm shaft), CoolSeal…Bolder Surgical, LLC2021—
+2K253634CoolSeal Generator® (CSL-200-90)Hologic, Inc.2026—
+3K231012CoolSeal TrinityBolder Surgical, LLC2023—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199540
199610

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202010
202130
202310
202610
FIG. 1 — Lineage of K160602, 1994–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K231790 The InMode System with the Morpheus8 Applicatorsscore 32.7 · 21 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K123662The Justright Surgical Vessel Sealing System
Summary page 4
…Electrosurgical, Cutting & Coagulation and Accessories Regulation Number(s): 878.4400 Predicate Devices: JustRight Surgical® Vessel Sealing System K123662 LigaSure™ Vessel Sealing System K981916 Force Triad™ Electrosurgical Ge…
Justright Surgical, LLC2013—
*K981916Ligasure Vessel Sealing System
Summary page 4
…on Number(s): 878.4400 Predicate Devices: JustRight Surgical® Vessel Sealing System K123662 LigaSure™ Vessel Sealing System K981916 Force Triad™ Electrosurgical Generator K070162 Intended Use: The JustRight Surgical® Vessel Sealing…
Valleylab, Inc.1998—
*K070162Forcetriad Electrosurgical Generator; Ligasure Instruments
Summary page 4
…l® Vessel Sealing System K123662 LigaSure™ Vessel Sealing System K981916 Force Triad™ Electrosurgical Generator K070162 Intended Use: The JustRight Surgical® Vessel Sealing System is indicated for use in open and laparoscopic general surgical proced…
Valleylab,A Division of Tyco Healthcare Group LP2007—

What descends from it? (6)

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K202114CoolSeal Generator/CSL-200-50, CoolSeal Trinity (30 cm shaft)/CSL-TR105-30, CoolSeal…Bolder Surgical, LLC20204
K203183CoolSeal Trinity (30 cm shaft, 37 cm shaft, and 44 cm shaft)Bolder Surgical, LLC20212
K203640CoolSeal RevealBolder Surgical, LLC20210

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 22 years and passes through 6 companies; a new generation was cleared every 4.1 years on median.
  • 1 of the 10 ancestors has a recall of any class.
  • Of its descendants, K202114 (Bolder Surgical, LLC, 2020) has gone furthest, with 4 descendants of its own.

How does its category compare?

All GEI devices

GEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.

FDA decisions per year · GEI

52in 2025

2007: 502008: 612009: 422010: 462011: 352012: 392013: 482014: 492015: 472016: 642017: 522018: 472019: 482020: 592021: 462022: 552023: 652024: 592025: 522026 (partial year): 43
2007high 65 (2023) · low 35 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GEI

113in 2025

2007: 51 days median2008: 71 days median2009: 130 days median2010: 109 days median2011: 135 days median2012: 133 days median2013: 136 days median2014: 103 days median2015: 123 days median2016: 108 days median2017: 72 days median2018: 93 days median2019: 93 days median2020: 105 days median2021: 146 days median2022: 150 days median2023: 104 days median2024: 125 days median2025: 113 days median2026 (partial year): 183 days median
2007high 183 (2026) · low 51 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · GEI

4in 2025

2007: 212008: 192009: 272010: 512011: 322012: 302013: 132014: 32015: 42016: 32017: 22018: 62019: 52020: 12021: 62022: 492023: 27, 4 Class I2024: 22, 10 Class I2025: 42026 (partial year): 8
2007high 51 (2010) · low 1 (2020)2026

Class I (14 since 2007) Class II/III not classified

Adverse event reports per year · GEI

7,592in 2025

2007: 2,7952008: 2,5562009: 3,5912010: 3,3772011: 4,4632012: 5,2162013: 4,8972014: 4,9082015: 4,9362016: 5,6162017: 6,0732018: 6,5452019: 7,0672020: 6,4902021: 6,3542022: 6,1032023: 7,1762024: 7,8972025: 7,592
2007high 7,897 (2024) · low 2,556 (2008)2025

MAUDE reports naming product code GEI, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20075051212,795
20086171192,556
200942130273,591
201046109513,377
201135135324,463
201239133305,216
201348136134,897
20144910334,908
20154712344,936
20166410835,616
2017527226,073
2018479366,545
2019489357,067
20205910516,490
20214614666,354
202255150496,103
20236510427 (4)7,176
20245912522 (10)7,897
20255211347,592
2026431838—

What is it indicated for?

The JustRight Surgical® Vessel Sealing System is indicated for use in open and laparoscopic general surgical procedures to seal blood vessels and vascular bundles up to and including 5 mm in diameter for use in adult and pediatric populations, wherever vessel ligation is required.

The device is contraindicated for use in ENT procedures.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Recent decisions in GEI

The GEI category page

  • K262386SafeAir Electrosurgical Generator with Smoke Evacuation (0795-001-000);SafeAir Generator 3-Pedal Footswitch…Stryker Instruments · 2026
  • K261959Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, Push Button Switch…Stryker Instruments · 2026
  • K254196HARMONIC 1100 Shears (HAR1120); HARMONIC 1100 Shears (HAR1136)Ethicon Endo-Surgery, LLC · 2026
  • K261070LigaSure™ RAS Maryland Jaw Vessel Sealer/Divider, Nano-coatedCovidien, LLC · 2026
  • K254185Potenza PrimeJeisys Medical Incorporated · 2026

https://510kreport.com/device/K160602 · printed Nov 6, 2026

Cite this page

510(k) Report. “K160602: JustRight Surgical Vessel Sealing System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K160602

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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