510(k) Report

510(k) · Cleared

Cleared

Valleylab Coated Electrodes

K962044510(k) TraditionalCleared Aug 30, 199694-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 Aug 30, 1996 after a 94-day review. The FDA summary names no predicate by number. 73 later devices descend from it.

Decided
Aug 30, 1996
Review
94 days
Class
Class II
Product code
GEI
Recalls
None
Predicates
0

73 later devices descend from it, 8 citing it directly.

Descendants, by year cleared 2006: 2 descendants cleared2008: 4 descendants cleared1999: 2 descendants cleared2015: 5 descendants cleared2009: 1 descendant cleared2018: 5 descendants cleared2016: 8 descendants cleared2019: 2 descendants cleared2010: 4 descendants cleared2003: 1 descendant cleared2005: 2 descendants cleared2012: 4 descendants cleared2004: 1 descendant cleared2014: 7 descendants cleared2011: 1 descendant cleared2013: 2 descendants cleared2024: 2 descendants cleared2020: 5 descendants cleared2022: 4 descendants cleared2026: 2 descendants cleared2017: 4 descendants cleared2021: 2 descendants cleared2023: 1 descendant cleared2025: 2 descendants cleared1995200020052010201520202025
  1. This deviceK962044 Valleylab Coated ElectrodesValleylab, Inc. · 1996
  2. Descendant · cites it directly · 33 of its ownK073057 Pulsar Generator, Model PS100-100, and Peak Plasmablade Tissue…Peak Surgical, Inc. · 2008
  3. Descendant · cites it directly · 33 of its ownK990362 Instrument, Ultrasonic, ScalpelEthicon Endo-Surgery, Inc. · 1999
  4. Descendant · cites it directly · 25 of its ownK073616 Fas-Clean Electrosurgical Coated Active BladeElectromedics Co., Ltd. · 2008
  5. Descendant · 2 generations on · 24 of its ownK082786 Pulsar Generator, Peak Plasmablade; 4.0, Needle, and Ext Tissue…Peak Surgical, Inc. · 2008 · Recalled
  6. Descendant · 2 generations on · 18 of its ownK100597 Harmonic Focus ShearsEthicon Endo-Surgery, LLC · 2010

Showing 5 of 73 descendants. See all descendants

Descendants cleared per year

1999: 22003: 12004: 12005: 22006: 22008: 42009: 12010: 42011: 12012: 42013: 22014: 72015: 52016: 82017: 42018: 52019: 22020: 52021: 22022: 42023: 12024: 22025: 22026: 2
1999high 8 (2016) · low 0 (2000)2026

Most influential descendants

Showing 5 of 73 · See all
  • K073057Pulsar Generator, Model PS100-100, and Peak Plasmablade Tissue Dissection Device, Model…Peak Surgical, Inc. · 2008 · cites it directly33descendants
  • K990362Instrument, Ultrasonic, ScalpelEthicon Endo-Surgery, Inc. · 1999 · cites it directly33descendants
  • K073616Fas-Clean Electrosurgical Coated Active BladeElectromedics Co., Ltd. · 2008 · cites it directly25descendants
  • K082786Pulsar Generator, Peak Plasmablade; 4.0, Needle, and Ext Tissue Dissection DevicesPeak Surgical, Inc. · 2008 · 2 generations on24descendants
  • K100597Harmonic Focus ShearsEthicon Endo-Surgery, LLC · 2010 · 2 generations on18descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K962044Valleylab Coated ElectrodesValleylab, Inc.1996—
+1K073057Pulsar Generator, Model PS100-100, and Peak Plasmablade Tissue Dissection…Peak Surgical, Inc.2008—
+1K990362Instrument, Ultrasonic, ScalpelEthicon Endo-Surgery, Inc.1999—
+1K073616Fas-Clean Electrosurgical Coated Active BladeElectromedics Co., Ltd.2008—
+2K082786Pulsar Generator, Peak Plasmablade; 4.0, Needle, and Ext Tissue Dissection…Peak Surgical, Inc.20081
+2K100597Harmonic Focus ShearsEthicon Endo-Surgery, LLC2010—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199920
200310
200410
200520
200620
200840
200910
201040
201110
201240
201320
201470
201550
201680
201740
201850
201920
202050
202120
202240
202310
202420
202520
202620
FIG. 1 — Lineage of K962044, 1996–2026Source: 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?

The FDA summary names no predicate by number.

What descends from it? (73)

See all 73

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

NumberDeviceApplicantDecidedDescendants
K073057Pulsar Generator, Model PS100-100, and Peak Plasmablade Tissue Dissection Device, Model…Peak Surgical, Inc.200833
K990362Instrument, Ultrasonic, ScalpelEthicon Endo-Surgery, Inc.199933
K073616Fas-Clean Electrosurgical Coated Active BladeElectromedics Co., Ltd.200825
K142410Elliquence ElectrodesElliquence, LLC20157
K081559GenesisMedisiss20080
K061878Electrode Coated Ball, Model AB302C; Needle, Model AN301C; Blade, Model AE301HCE Surgical, LLC20060
K052297Porex Electrosurgery NeedlePorex Surgical, Inc.20060
K984275The Golden Tip Electro-Surgical ProbeAmada Surgical19990

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, K073057 (Peak Surgical, Inc., 2008) has gone furthest, with 33 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—

What is it indicated for?

Valleylab Coated Electrodes are intended as an alternative to uncoated stainless steel electrodes or “non-stick” coated electrodes for use in conventional monopolar electrosurgical accessories. The Coated Electrodes are intended for use in situations where monopolar electrosurgical cutting and coagulation are normally used.

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

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/K962044 · printed Nov 4, 2026

Cite this page

510(k) Report. “K962044: Valleylab Coated Electrodes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K962044

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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