510(k) Report

510(k) · Cleared

Cleared

Erbotom Icc 200

K933157510(k) TraditionalCleared Feb 23, 1994239-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 Feb 23, 1994 after a 239-day review. The FDA summary names its predicate without a number. 144 later devices descend from it.

Decided
Feb 23, 1994
Review
239 days
Class
Class II
Product code
GEI
Recalls
None
Predicates
0

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

Descendants, by year cleared 2001: 1 descendant cleared2011: 5 descendants cleared2008: 5 descendants cleared2007: 1 descendant cleared2006: 2 descendants cleared2012: 7 descendants cleared1999: 1 descendant cleared2013: 7 descendants cleared2020: 9 descendants cleared2005: 2 descendants cleared2009: 4 descendants cleared2010: 8 descendants cleared2019: 4 descendants cleared2025: 16 descendants cleared2002: 1 descendant cleared2015: 6 descendants cleared2018: 5 descendants cleared2023: 7 descendants cleared2017: 8 descendants cleared2016: 8 descendants cleared2021: 5 descendants cleared2024: 10 descendants cleared2014: 5 descendants cleared2022: 9 descendants cleared2026: 8 descendants cleared1990200020102020
  1. This deviceK933157 Erbotom Icc 200Erbe USA, Inc. · 1994
  2. Descendant · cites it directly · 104 of its ownK013255 Surgitron 120 Iec (Also Known as Surgitron 4.0 Dual RFEllman Intl., Inc. · 2001
  3. Descendant · 2 generations on · 56 of its ownK082834 Ellman International Non-Ablative Technique for Surgitron IecEllman Int'L, Inc. · 2009 · Recalled
  4. Descendant · 3 generations on · 53 of its ownK101967 Non-Ablative Wrinkle Treatent Handpiece Modle Pelleve'Ellman Int'L, Inc. · 2010
  5. Descendant · 4 generations on · 52 of its ownK102368 Non-Ablative Wrinkle Treatment HandpieceEllman Int'L, Inc. · 2010
  6. Descendant · 3 generations on · 39 of its ownK102698 Pelleve Glidesafe Non-Ablative Wrinkle Treatment System Model…Ellman Int'L, Inc. · 2011

Showing 5 of 144 descendants. See all descendants

Descendants cleared per year

1999: 12001: 12002: 12005: 22006: 22007: 12008: 52009: 42010: 82011: 52012: 72013: 72014: 52015: 62016: 82017: 82018: 52019: 42020: 92021: 52022: 92023: 72024: 102025: 162026: 8
1999high 16 (2025) · low 0 (2000)2026

Most influential descendants

Showing 5 of 144 · See all
  • K013255Surgitron 120 Iec (Also Known as Surgitron 4.0 Dual RFEllman Intl., Inc. · 2001 · cites it directly104descendants
  • K082834Ellman International Non-Ablative Technique for Surgitron IecEllman Int'L, Inc. · 2009 · 2 generations on56descendants
  • K101967Non-Ablative Wrinkle Treatent Handpiece Modle Pelleve'Ellman Int'L, Inc. · 2010 · 3 generations on53descendants
  • K102368Non-Ablative Wrinkle Treatment HandpieceEllman Int'L, Inc. · 2010 · 4 generations on52descendants
  • K102698Pelleve Glidesafe Non-Ablative Wrinkle Treatment System Model Pelleve GlidesafeEllman Int'L, Inc. · 2011 · 3 generations on39descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K933157Erbotom Icc 200Erbe USA, Inc.1994—
+1K013255Surgitron 120 Iec (Also Known as Surgitron 4.0 Dual RFEllman Intl., Inc.2001—
+2K082834Ellman International Non-Ablative Technique for Surgitron IecEllman Int'L, Inc.20091
+3K101967Non-Ablative Wrinkle Treatent Handpiece Modle Pelleve'Ellman Int'L, Inc.2010—
+4K102368Non-Ablative Wrinkle Treatment HandpieceEllman Int'L, Inc.2010—
+3K102698Pelleve Glidesafe Non-Ablative Wrinkle Treatment System Model Pelleve GlidesafeEllman Int'L, Inc.2011—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199910
200110
200210
200520
200620
200710
200850
200940
201080
201150
201270
201370
201450
201560
201680
201780
201850
201940
202090
202150
202290
202370
2024100
2025160
202680
FIG. 1 — Lineage of K933157, 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? (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
*—ACC 450
Named without a submission number
—

What descends from it? (144)

See all 144

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

NumberDeviceApplicantDecidedDescendants
K013255Surgitron 120 Iec (Also Known as Surgitron 4.0 Dual RFEllman Intl., Inc.2001104
K062712Erbe Monopolar Attachment for Helix Hydro-Jet, Model P/N 20139-094Erbe USA, Inc.200714
K073207Olympus Esg-100, Model WB991046; Olympus Afu-100, Model WB950167Celon AG Medical Instruments20087
K992382Surgitron RadiolaseEllman Intl., Inc.19997
K100669Canady Plasma Electrosurgical Unit Series with Accessory Probes and BladesUs Medical Innovations, LLC20112
K061884Bovie Icon GI Electrosurgical Generator, Model GI 120Bovie Medical20062
K113265Genii GI 4000 Electrosugical GeneratorGenii, Inc.20121
K081678Conmed Beamer System C600Kls Martin GmbH + Co. KG20081

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, K013255 (Ellman Intl., Inc., 2001) has gone furthest, with 104 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 Erbe USA, Inc.

39 FDA decisions under this applicant name. See the company

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  • 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/K933157 · printed Nov 6, 2026

Cite this page

510(k) Report. “K933157: Erbotom Icc 200.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K933157

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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