510(k) Report

510(k) · Cleared

Cleared

Valleylab NS 2000 Bipolar Generator System

K946177510(k) TraditionalCleared Jun 6, 1995169-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

Valleylab, Inc. · GEI Electrosurgical, Cutting & Coagulation & Accessories

Cleared on Jun 6, 1995 after a 169-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 203 later devices descend from it.

Decided
Jun 6, 1995
Review
169 days
Class
Class II
Product code
GEI
Recalls
None
Predicates
0

203 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 1998: 1 descendant cleared2016: 16 descendants cleared2005: 3 descendants cleared2013: 8 descendants cleared2003: 3 descendants cleared2008: 6 descendants cleared2014: 10 descendants cleared2006: 6 descendants cleared2010: 4 descendants cleared2004: 3 descendants cleared2009: 2 descendants cleared2011: 9 descendants cleared2012: 5 descendants cleared2007: 5 descendants cleared2015: 14 descendants cleared2017: 13 descendants cleared2018: 18 descendants cleared2021: 12 descendants cleared2020: 9 descendants cleared2022: 10 descendants cleared2019: 6 descendants cleared2026: 10 descendants cleared2025: 7 descendants cleared2023: 12 descendants cleared2024: 11 descendants cleared1995200020052010201520202025
  1. This deviceK946177 Valleylab NS 2000 Bipolar Generator SystemValleylab, Inc. · 1995
  2. Descendant · cites it directly · 202 of its ownK981916 Ligasure Vessel Sealing SystemValleylab, Inc. · 1998
  3. Descendant · 2 generations on · 128 of its ownK051644 Valleylab Forcetriad Electrosurgical GeneratorValleylab · 2005
  4. Descendant · 2 generations on · 114 of its ownK031011 Ligasure 5MM Laparoscopic Sealer-Divider, Model LS1500Valleylab, Inc. · 2003 · Recalled
  5. Descendant · 3 generations on · 102 of its ownK070162 Forcetriad Electrosurgical Generator; Ligasure InstrumentsValleylab,A Division of Tyco Healthcare Group LP · 2007
  6. Descendant · 3 generations on · 65 of its ownK092879 Ligasure 5MM Blunt Tip Laparoscopic Sealer-DividerValleylab · 2009 · Recalled

Showing 5 of 203 descendants. See all descendants

Descendants cleared per year

1998: 12003: 32004: 32005: 32006: 62007: 52008: 62009: 22010: 42011: 92012: 52013: 82014: 102015: 142016: 162017: 132018: 182019: 62020: 92021: 122022: 102023: 122024: 112025: 72026: 10
1998high 18 (2018) · low 0 (1999)2026

Most influential descendants

Showing 5 of 203 · See all
  • K981916Ligasure Vessel Sealing SystemValleylab, Inc. · 1998 · cites it directly202descendants
  • K051644Valleylab Forcetriad Electrosurgical GeneratorValleylab · 2005 · 2 generations on128descendants
  • K031011Ligasure 5MM Laparoscopic Sealer-Divider, Model LS1500Valleylab, Inc. · 2003 · 2 generations on114descendants
  • K070162Forcetriad Electrosurgical Generator; Ligasure InstrumentsValleylab,A Division of Tyco Healthcare Group LP · 2007 · 3 generations on102descendants
  • K092879Ligasure 5MM Blunt Tip Laparoscopic Sealer-DividerValleylab · 2009 · 3 generations on65descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K946177Valleylab NS 2000 Bipolar Generator SystemValleylab, Inc.1995—
+1K981916Ligasure Vessel Sealing SystemValleylab, Inc.1998—
+2K051644Valleylab Forcetriad Electrosurgical GeneratorValleylab2005—
+2K031011Ligasure 5MM Laparoscopic Sealer-Divider, Model LS1500Valleylab, Inc.20032
+3K070162Forcetriad Electrosurgical Generator; Ligasure InstrumentsValleylab,A Division of Tyco Healthcare Group LP2007—
+3K092879Ligasure 5MM Blunt Tip Laparoscopic Sealer-DividerValleylab20091

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199810
200330
200430
200530
200660
200750
200860
200920
201040
201190
201250
201380
2014100
2015140
2016160
2017130
2018180
201960
202090
2021120
2022100
2023120
2024110
202570
2026100
FIG. 1 — Lineage of K946177, 1995–2026Source: 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), 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
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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (203)

See all 203

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K981916Ligasure Vessel Sealing SystemValleylab, Inc.1998202

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?

  • Of its descendants, K981916 (Valleylab, Inc., 1998) has gone furthest, with 202 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.

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—

More from Valleylab, Inc.

94 FDA decisions under this applicant name. See the company

  • K031011Ligasure 5MM Laparoscopic Sealer-Divider, Model LS1500Valleylab, Inc. · 20032 recalls
  • K010010Valleylab Ligasure Precise Instrument Vessel Sealing System-Model # LS1200 & Sligaure GeneratorValleylab, Inc. · 2001
  • K010013Ligasure Laparoscopic Sealer Divider Model LS1100Valleylab, Inc. · 20012 recalls
  • K994428E7512 Premie Rem Polyhesive II Patient Return ElectrodeValleylab, Inc. · 2000
  • K983743Bisure Laparoscopic Bipolar ForcepsValleylab, Inc. · 1999

Recent decisions in GEI

The GEI category page

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  • K261070LigaSure™ RAS Maryland Jaw Vessel Sealer/Divider, Nano-coatedCovidien, LLC · 2026
  • K254185Potenza PrimeJeisys Medical Incorporated · 2026

https://510kreport.com/device/K946177 · printed Nov 5, 2026

Cite this page

510(k) Report. “K946177: Valleylab NS 2000 Bipolar Generator System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K946177

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026