510(k) Report

510(k) · Cleared

Cleared

Valleylab Laparoscopic Handswitch/Electrodes

K904560510(k) TraditionalCleared Dec 31, 199087-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 Dec 31, 1990 after an 87-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 41 later devices descend from it.

Decided
Dec 31, 1990
Review
87 days
Class
Class II
Product code
GEI
Recalls
None
Predicates
0

41 later devices descend from it, 6 citing it directly.

Descendants, by year cleared 2006: 2 descendants cleared1999: 2 descendants cleared2016: 6 descendants cleared1997: 1 descendant cleared2015: 2 descendants cleared2008: 2 descendants cleared2019: 1 descendant cleared2023: 2 descendants cleared2020: 3 descendants cleared2012: 1 descendant cleared2011: 1 descendant cleared2024: 4 descendants cleared2014: 2 descendants cleared2025: 3 descendants cleared2017: 3 descendants cleared2021: 1 descendant cleared2018: 2 descendants cleared2022: 1 descendant cleared2026: 2 descendants cleared1990200020102020
  1. This deviceK904560 Valleylab Laparoscopic Handswitch/ElectrodesValleylab, Inc. · 1990
  2. Descendant · cites it directly · 31 of its ownK063195 Ligasure Advance Laparoscopic Sealer/Divider with Dissecting…Valleylab · 2006
  3. Descendant · 2 generations on · 24 of its ownK081129 Enseal…Surgrx, Inc. · 2008
  4. Descendant · 3 generations on · 11 of its ownK111202 Surgical Tissue Management SystemOlympus Medical Systems Corp. · 2012 · Recalled
  5. Descendant · 3 generations on · 11 of its ownK101990 Ethicon Endo-Surgery Generator G11, Model GEN11Ethicon Endo-Sugery, LLC · 2011
  6. Descendant · 4 generations on · 9 of its ownK141122 Harmonic Scallop Blade, Generator G11Ethicon Endo-Surgery, LLC · 2014

Showing 5 of 41 descendants. See all descendants

Descendants cleared per year

1997: 11999: 22006: 22008: 22011: 12012: 12014: 22015: 22016: 62017: 32018: 22019: 12020: 32021: 12022: 12023: 22024: 42025: 32026: 2
1997high 6 (2016) · low 0 (1998)2026

Most influential descendants

Showing 5 of 41 · See all
  • K063195Ligasure Advance Laparoscopic Sealer/Divider with Dissecting Electrode, Models LF5034…Valleylab · 2006 · cites it directly31descendants
  • K081129Enseal Powertip,Nseal-514D,-525D,-535D,-545D,-514RD,-525RD,-535RD,-545RD…Surgrx, Inc. · 2008 · 2 generations on24descendants
  • K111202Surgical Tissue Management SystemOlympus Medical Systems Corp. · 2012 · 3 generations on11descendants
  • K101990Ethicon Endo-Surgery Generator G11, Model GEN11Ethicon Endo-Sugery, LLC · 2011 · 3 generations on11descendants
  • K141122Harmonic Scallop Blade, Generator G11Ethicon Endo-Surgery, LLC · 2014 · 4 generations on9descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K904560Valleylab Laparoscopic Handswitch/ElectrodesValleylab, Inc.1990—
+1K063195Ligasure Advance Laparoscopic Sealer/Divider with Dissecting Electrode, Models…Valleylab2006—
+2K081129Enseal Powertip,Nseal-514D,-525D,-535D,-545D,-514RD,-525RD,-535RD,-545RD…Surgrx, Inc.2008—
+3K111202Surgical Tissue Management SystemOlympus Medical Systems Corp.201210
+3K101990Ethicon Endo-Surgery Generator G11, Model GEN11Ethicon Endo-Sugery, LLC2011—
+4K141122Harmonic Scallop Blade, Generator G11Ethicon Endo-Surgery, LLC2014—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199710
199920
200620
200820
201110
201210
201420
201520
201660
201730
201820
201910
202030
202110
202210
202320
202440
202530
202620
FIG. 1 — Lineage of K904560, 1990–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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
Get a 510(k) Report

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? (41)

See all 41

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

NumberDeviceApplicantDecidedDescendants
K063195Ligasure Advance Laparoscopic Sealer/Divider with Dissecting Electrode, Models LF5034…Valleylab200631
K153265New Deantronics Disposable Laparoscopic Electrodes, non-coated, and coatedNew Deantronics Taiwan, Ltd.20163
K970140E0520-Trigger Switch and Cord/E0521-Trigger SwitchValleylab, Inc.19972
K161804LigaSure Retractable L-Hook Laparoscopic Sealer/DividerCovidien20160
K992764Erbe Apc Raspatory Handle and Tip, Model 20132-102, 20132-103Erbe USA, Inc.19990
K984239Slicktip Solid Laparoscopic Electrode, Models LH01Z, LB02Z, LN03Z, LC04Z, LS05Z, LL06Z…Aaron Medical Industries19990

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, K063195 (Valleylab, 2006) has gone furthest, with 31 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

  • 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/K904560 · printed Nov 4, 2026

Cite this page

510(k) Report. “K904560: Valleylab Laparoscopic Handswitch/Electrodes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K904560

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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