510(k) Report

510(k) · Cleared

Cleared

Erbe Vio Esu with Accessories, Model Vio 300 D

K023886510(k) SpecialCleared Dec 12, 200221-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

Erbe USA, Inc. · GEI Electrosurgical, Cutting & Coagulation & Accessories

Cleared on Dec 12, 2002 as substantially equivalent to K933002 (Erbe USA, Inc., 1994) after a 21-day review. Its family tree reaches back 1 generation to 1994. 136 later devices descend from it.

Decided
Dec 12, 2002
Review
21 days
Class
Class II
Product code
GEI
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K933002 (1994). 136 later devices descend from it, 9 citing it directly.

Descendants, by year cleared 2011: 4 descendants cleared2005: 1 descendant cleared2018: 8 descendants cleared2008: 4 descendants cleared2017: 12 descendants cleared2006: 2 descendants cleared2007: 2 descendants cleared2012: 3 descendants cleared2010: 2 descendants cleared2013: 2 descendants cleared2019: 14 descendants cleared2020: 8 descendants cleared2022: 13 descendants cleared2016: 5 descendants cleared2014: 5 descendants cleared2025: 12 descendants cleared2009: 1 descendant cleared2015: 3 descendants cleared2021: 8 descendants cleared2024: 10 descendants cleared2023: 13 descendants cleared2026: 4 descendants clearedK933002 · Erbotom Icc 350 · Erbe USA, Inc. · 19941990200020102020
Descendants, by generation 1 generation forward: 9 descendants2 generations forward: 25 descendants3 generations forward: 29 descendants4 generations forward: 25 descendants5 generations forward: 21 descendants6 generations forward: 16 descendants7 generations forward: 7 descendants8 generations forward: 4 descendants K933002 · Erbotom Icc 350 · Erbe USA, Inc. · 19940+5
  1. Root · 1 generation backK933002 Erbotom Icc 350Erbe USA, Inc. · 1994
  2. This deviceK023886 Erbe Vio Esu with Accessories, Model Vio 300 DErbe USA, Inc. · 2002
  3. Descendant · cites it directly · 115 of its ownK060484 Erbe Vio Esu, Model Vio 300 DErbe USA, Inc. · 2006
  4. Descendant · cites it directly · 55 of its ownK083452 Erbe Model Vio 300 D with AccessoriesErbe USA, Inc. · 2008
  5. Descendant · 2 generations on · 39 of its ownK134054 Bovie Ids-310 High Frequency Electrosurgical Generator, Aaron A3350…Bovie Medical Corporation · 2014
  6. Descendant · 2 generations on · 16 of its ownK110268 Forcetriad Electrosurgical GeneratorCovidien Lp, Formerly Know AS Valleylab, A Divison · 2011
  7. Descendant · 2 generations on · 16 of its ownK071728 Modification to: Enseal PTC Tissue Sealing DeviceSurgrx, Inc. · 2007

Showing 5 of 136 descendants. See all descendants

Descendants cleared per year

2005: 12006: 22007: 22008: 42009: 12010: 22011: 42012: 32013: 22014: 52015: 32016: 52017: 122018: 82019: 142020: 82021: 82022: 132023: 132024: 102025: 122026: 4
2005high 14 (2019) · low 1 (2005)2026

Most influential descendants

Showing 5 of 136 · See all
  • K060484Erbe Vio Esu, Model Vio 300 DErbe USA, Inc. · 2006 · cites it directly115descendants
  • K083452Erbe Model Vio 300 D with AccessoriesErbe USA, Inc. · 2008 · cites it directly55descendants
  • K134054Bovie Ids-310 High Frequency Electrosurgical Generator, Aaron A3350 High Frequency…Bovie Medical Corporation · 2014 · 2 generations on39descendants
  • K110268Forcetriad Electrosurgical GeneratorCovidien Lp, Formerly Know AS Valleylab, A Divison · 2011 · 2 generations on16descendants
  • K071728Modification to: Enseal PTC Tissue Sealing DeviceSurgrx, Inc. · 2007 · 2 generations on16descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K933002Erbotom Icc 350Erbe USA, Inc.1994—
0 (this device)K023886Erbe Vio Esu with Accessories, Model Vio 300 DErbe USA, Inc.2002—
+1K060484Erbe Vio Esu, Model Vio 300 DErbe USA, Inc.2006—
+1K083452Erbe Model Vio 300 D with AccessoriesErbe USA, Inc.2008—
+2K134054Bovie Ids-310 High Frequency Electrosurgical Generator, Aaron A3350 High…Bovie Medical Corporation2014—
+2K110268Forcetriad Electrosurgical GeneratorCovidien Lp, Formerly Know AS Valleylab, A Divison2011—
+2K071728Modification to: Enseal PTC Tissue Sealing DeviceSurgrx, Inc.2007—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200510
200620
200720
200840
200910
201020
201140
201230
201320
201450
201530
201650
2017120
201880
2019140
202080
202180
2022130
2023130
2024100
2025120
202640
FIG. 1 — Lineage of K023886, 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
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What was it cleared against? (1)

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
*K933002Erbotom Icc 350
Summary page 1
…(21CFR878.4400) Product Code: 79GEI Leaallv Marketed ERBE ERBOTOM ESU (Model ICC 350 E) Predicate Device: 51O(k) Number: K933002 Device Description: The ERBE VI0 ESU with Accessories is an electrosurgical system that uses high frequency (hf) electrical cur…
Erbe USA, Inc.1994—

Also cleared against K933002: 3 other devices →

What descends from it? (136)

See all 136

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

NumberDeviceApplicantDecidedDescendants
K060484Erbe Vio Esu, Model Vio 300 DErbe USA, Inc.2006115
K083452Erbe Model Vio 300 D with AccessoriesErbe USA, Inc.200855
K103032Esg-400 Model WB95051N, Footswitch Double Pedal Model WB50402W, Footswitch Single Pedal…Olympus Winter & Ibe GmbH201112
K162979Veloxion SystemCorinth Medtech, Inc.20177
K073207Olympus Esg-100, Model WB991046; Olympus Afu-100, Model WB950167Celon AG Medical Instruments20087
K180752Veloxion System, Veloxion Controller Kit, Veloxion Resecting Device Kit, Veloxion Fluid…Corinth Medtech, Inc.20182
K100669Canady Plasma Electrosurgical Unit Series with Accessory Probes and BladesUs Medical Innovations, LLC20112
K081678Conmed Beamer System C600Kls Martin GmbH + Co. KG20081
K042274PSD-60/EndoplasmaOlympus Shirakawa Co., Ltd.20050

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?

  • Its one ancestor has no recall.
  • Of its descendants, K060484 (Erbe USA, Inc., 2006) has gone furthest, with 115 descendants of its own.
  • 3 other devices also cite its predicate K933002.

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?

High Frequency Electrical Current for the Cutting and/or Coagulation of Tissue

Indications for use as stated in the FDA summary.

Also cleared against K933002

3 other devices cite the same predicate.

  • K062712Erbe Monopolar Attachment for Helix Hydro-Jet, Model P/N 20139-094Erbe USA, Inc. · 2007
  • K014172Nelson Electrosurgical Unit, Model GN640Aesculap, Inc. · 2002
  • K990628Gyrus Endourology SystemGyrus Medical, Ltd. · 1999

More from Erbe USA, Inc.

39 FDA decisions under this applicant name. See the company

  • K221177Erbe's Tubing/Cap SetsErbe USA, Inc. · 20221 recall
  • K191438ERBEFLO 2 Endo Quick Connect Pentax Scope Port ConnectorErbe USA, Inc. · 2019
  • K190469ERBEFLO 2 Disposable Tubing SystemErbe USA, Inc. · 20191 recall
  • K182444ERBEFLO Olympus Scope Port ConnectorErbe USA, Inc. · 2018
  • K162152Erbe’s CO2 Tubing/Cap SetsErbe USA, Inc. · 20161 recall

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The GEI category page

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https://510kreport.com/device/K023886 · printed Nov 4, 2026

Cite this page

510(k) Report. “K023886: Erbe Vio Esu with Accessories, Model Vio 300 D.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K023886

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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