510(k) Report

510(k) · Cleared

Cleared

Erbe Monopolar Attachment for Helix Hydro-Jet, Model P/N 20139-094

K062712510(k) TraditionalCleared Jan 26, 2007137-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 Jan 26, 2007 as substantially equivalent to K033590 (Erbe USA, Inc., 2004) and 7 other predicates after a 137-day review. Its family tree reaches back 5 generations to 1995. 14 later devices descend from it.

Decided
Jan 26, 2007
Review
137 days
Class
Class II
Product code
GEI
Recalls
None
Predicates
8

Its longest line of descent runs back 5 generations to K952726 (1995). 17 ancestors in all, the oldest K933157 (1994). 14 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2006: 1 other ancestor1995: 2 other ancestors1994: 4 other ancestors2002: 1 other ancestor2000: 2 other ancestors1998: 1 other ancestor1997: 1 other ancestor2009: 1 descendant cleared2020: 3 descendants cleared2023: 2 descendants cleared2017: 1 descendant cleared2015: 1 descendant cleared2025: 3 descendants cleared2022: 1 descendant cleared2019: 1 descendant cleared2021: 1 descendant clearedK952726 · Ultracision Harmonic Scapel · Ultracision, Inc. · 1995K990430 · Ultracision Harmonic Scalpel Hand Piece · Ethicon Endo-Surgery, Inc. · 1999K012464 · Helix Hydro-Jet · Andreas Pein Medizintechnik GmbH · 2001K022613 · Helix Hydro-Jet · Erbe USA, Inc. · 2002K033590 · Erbe Helix Hydro-Jet · Erbe USA, Inc. · 20041990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 7 other ancestors2 generations back: 1 other ancestor4 generations back: 3 other ancestors5 generations back: 1 other ancestor 1 generation forward: 1 descendant2 generations forward: 4 descendants3 generations forward: 7 descendants4 generations forward: 2 descendants K033590 · Erbe Helix Hydro-Jet · Erbe USA, Inc. · 2004K022613 · Helix Hydro-Jet · Erbe USA, Inc. · 2002K012464 · Helix Hydro-Jet · Andreas Pein Medizintechnik GmbH · 2001K990430 · Ultracision Harmonic Scalpel Hand Piece · Ethicon Endo-Surgery, Inc. · 1999K952726 · Ultracision Harmonic Scapel · Ultracision, Inc. · 1995−50
  1. Root · 5 generations backK952726 Ultracision Harmonic ScapelUltracision, Inc. · 1995
  2. 4 generations backK990430 Ultracision Harmonic Scalpel Hand PieceEthicon Endo-Surgery, Inc. · 1999
  3. 3 generations backK012464 Helix Hydro-JetAndreas Pein Medizintechnik GmbH · 2001
  4. 2 generations backK022613 Helix Hydro-JetErbe USA, Inc. · 2002
  5. 1 generation backK033590 Erbe Helix Hydro-JetErbe USA, Inc. · 2004
  6. This deviceK062712 Erbe Monopolar Attachment for Helix Hydro-Jet, Model P/N 20139-094Erbe USA, Inc. · 2007
  7. Descendant · cites it directly · 13 of its ownK083608 Erbe Hybrid KnifeErbe USA, Inc. · 2009
  8. Descendant · 2 generations on · 12 of its ownK143306 ERBE WaterJet Model ERBEJET® 2 System with HybridAPC ProbeErbe USA, Inc. · 2015
  9. Descendant · 2 generations on · 7 of its ownK171158 Single Use Electrosurgical knifeOlympus Medical Systems Corp. · 2017 · Recalled
  10. Descendant · 3 generations on · 1 of its ownK243120 HybridAPC probeErbe Elektromedizin GmbH · 2025
  11. Descendant · 3 generations on · 1 of its ownK231023 ERBEJET® 2 SystemErbe Elektromedizin GmbH · 2023

Showing 5 of 14 descendants. See all descendants

Descendants cleared per year

2009: 12015: 12017: 12019: 12020: 32021: 12022: 12023: 22025: 3
2009high 3 (2020) · low 0 (2010)2026

Most influential descendants

Showing 5 of 14 · See all
  • K083608Erbe Hybrid KnifeErbe USA, Inc. · 2009 · cites it directly13descendants
  • K143306ERBE WaterJet Model ERBEJET® 2 System with HybridAPC ProbeErbe USA, Inc. · 2015 · 2 generations on12descendants
  • K171158Single Use Electrosurgical knifeOlympus Medical Systems Corp. · 2017 · 2 generations on7descendants
  • K243120HybridAPC probeErbe Elektromedizin GmbH · 2025 · 3 generations on1descendant
  • K231023ERBEJET® 2 SystemErbe Elektromedizin GmbH · 2023 · 3 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−5K952726Ultracision Harmonic ScapelUltracision, Inc.1995—
−4K990430Ultracision Harmonic Scalpel Hand PieceEthicon Endo-Surgery, Inc.1999—
−3K012464Helix Hydro-JetAndreas Pein Medizintechnik GmbH2001—
−2K022613Helix Hydro-JetErbe USA, Inc.2002—
−1K033590Erbe Helix Hydro-JetErbe USA, Inc.2004—
0 (this device)K062712Erbe Monopolar Attachment for Helix Hydro-Jet, Model P/N 20139-094Erbe USA, Inc.2007—
+1K083608Erbe Hybrid KnifeErbe USA, Inc.2009—
+2K143306ERBE WaterJet Model ERBEJET® 2 System with HybridAPC ProbeErbe USA, Inc.2015—
+2K171158Single Use Electrosurgical knifeOlympus Medical Systems Corp.20172
+3K243120HybridAPC probeErbe Elektromedizin GmbH2025—
+3K231023ERBEJET® 2 SystemErbe Elektromedizin GmbH2023—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199440
199520
199710
199810
200020
200210
200610

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200910
201510
201710
201910
202030
202110
202210
202320
202530
FIG. 1 — Lineage of K062712, 1995–2025Source: 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? (8)

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
*K033590Erbe Helix Hydro-Jet
Summary page 1
…agulation device and accessories (21 CFR 878.4400) Product Code: FQH and GEl Legally Marketed ERBE Helix Hydro-Jet TM System, 510(k) Number: K033590 Predicate Devices: ERBE ESU (ICC or VIO Models) Systems, 510(k) Numbers: K953738; K953…
Erbe USA, Inc.2004—
*K953738Erbotom Icc 300
Summary page 1
…RBE Helix Hydro-Jet TM System, 510(k) Number: K033590 Predicate Devices: ERBE ESU (ICC or VIO Models) Systems, 510(k) Numbers: K953738; K953159; K935815; K933002; K933157; K060484 ERBE Disposable Push Button Pencil, 510(k) Number: K93…
Erbe Electromedizin GmbH1995—
*K953159Erbotom Icc Bipolar
Summary page 1
…Hydro-Jet TM System, 510(k) Number: K033590 Predicate Devices: ERBE ESU (ICC or VIO Models) Systems, 510(k) Numbers: K953738; K953159; K935815; K933002; K933157; K060484 ERBE Disposable Push Button Pencil, 510(k) Number: K936304 Dev…
Erbe USA, Inc.1995—
*K935815Erbotom Icc 50
Summary page 1
…t TM System, 510(k) Number: K033590 Predicate Devices: ERBE ESU (ICC or VIO Models) Systems, 510(k) Numbers: K953738; K953159; K935815; K933002; K933157; K060484 ERBE Disposable Push Button Pencil, 510(k) Number: K936304 Device Descr…
Erbe USA, Inc.1994—
*K933002Erbotom Icc 350
Summary page 1
…em, 510(k) Number: K033590 Predicate Devices: ERBE ESU (ICC or VIO Models) Systems, 510(k) Numbers: K953738; K953159; K935815; K933002; K933157; K060484 ERBE Disposable Push Button Pencil, 510(k) Number: K936304 Device Description: G…
Erbe USA, Inc.1994—
*K933157Erbotom Icc 200
Summary page 1
…) Number: K033590 Predicate Devices: ERBE ESU (ICC or VIO Models) Systems, 510(k) Numbers: K953738; K953159; K935815; K933002; K933157; K060484 ERBE Disposable Push Button Pencil, 510(k) Number: K936304 Device Description: General De…
Erbe USA, Inc.1994—
*K060484Erbe Vio Esu, Model Vio 300 D
Summary page 1
…K033590 Predicate Devices: ERBE ESU (ICC or VIO Models) Systems, 510(k) Numbers: K953738; K953159; K935815; K933002; K933157; K060484 ERBE Disposable Push Button Pencil, 510(k) Number: K936304 Device Description: General Description…
Erbe USA, Inc.2006—
*K936304Electrosurgical Pencil
Summary page 1
…rs: K953738; K953159; K935815; K933002; K933157; K060484 ERBE Disposable Push Button Pencil, 510(k) Number: K936304 Device Description: General Description. The ERBE Monopolar Attachment [P/N 20139-094] is used with the Helix Hydro-Jet Tm and t…
E & M Engineering, Inc.19943

Also cleared against K033590: 1 other device →

What descends from it? (14)

See all 14

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

NumberDeviceApplicantDecidedDescendants
K083608Erbe Hybrid KnifeErbe USA, Inc.200913

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?

  • The line of descent spans 12 years and passes through 4 companies; a new generation was cleared every 2.6 years on median.
  • 2 of the 17 ancestors have a recall of any class.
  • Of its descendants, K083608 (Erbe USA, Inc., 2009) has gone furthest, with 13 descendants of its own.
  • 1 other device also cites its predicate K033590.

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. 2007, this device’s year, is highlighted.

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?

The Monopolar Attachment combines the use of the Helix Hydro-JetTM Applicator with suction (Part Number 20139-074) with the use of monopolar coagulation and cutting (optional drip irrigation is also available) when used in conjunction with an ERBE ESU (ICC or VIO Models).

Note: The Electrosurgical Unit (ESU) to be used must have a Monopolar 3-pin bovie receptacle. The use of ERBE ESU ICC and VIO Models are recommended. Compatibility and settings should be demonstrated/established prior to using a different Generator in the clinical environment.

Indications for use as stated in the FDA summary.

Also cleared against K033590

1 other device cites the same predicate.

  • K072404Erbe Erbejet 2 SystemErbe USA, Inc. · 2007

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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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https://510kreport.com/device/K062712 · printed Nov 6, 2026

Cite this page

510(k) Report. “K062712: Erbe Monopolar Attachment for Helix Hydro-Jet, Model P/N 20139-094.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K062712

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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