510(k) · Cleared
ClearedErbe Hybrid Knife
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Erbe USA, Inc. · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Aug 26, 2009 as substantially equivalent to K062712 (Erbe USA, Inc., 2007) and 1 other predicate after a 264-day review. Its family tree reaches back 6 generations to 1995. 13 later devices descend from it.
- Decided
- Aug 26, 2009
- Review
- 264 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K952726 (1995). 19 ancestors in all, the oldest K933157 (1994). 13 later devices descend from it, 4 citing it directly.
- Root · 6 generations backK952726 Ultracision Harmonic ScapelUltracision, Inc. · 1995
- 5 generations backK990430 Ultracision Harmonic Scalpel Hand PieceEthicon Endo-Surgery, Inc. · 1999
- 4 generations backK012464 Helix Hydro-JetAndreas Pein Medizintechnik GmbH · 2001
- 3 generations backK022613 Helix Hydro-JetErbe USA, Inc. · 2002
- 2 generations backK033590 Erbe Helix Hydro-JetErbe USA, Inc. · 2004
- 1 generation backK062712 Erbe Monopolar Attachment for Helix Hydro-Jet, Model P/N 20139-094Erbe USA, Inc. · 2007
- This deviceK083608 Erbe Hybrid KnifeErbe USA, Inc. · 2009
- Descendant · cites it directly · 12 of its ownK143306 ERBE WaterJet Model ERBEJET® 2 System with HybridAPC ProbeErbe USA, Inc. · 2015
- Descendant · cites it directly · 7 of its ownK171158 Single Use Electrosurgical knifeOlympus Medical Systems Corp. · 2017 · Recalled
- Descendant · 2 generations on · 1 of its ownK243120 HybridAPC probeErbe Elektromedizin GmbH · 2025
- Descendant · 2 generations on · 1 of its ownK231023 ERBEJET® 2 SystemErbe Elektromedizin GmbH · 2023
- Descendant · 2 generations on · 1 of its ownK193601 Single Use Electrosurgical KnifeMicro-Tech (Nanjing) Co., Ltd. · 2020
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K143306ERBE WaterJet Model ERBEJET® 2 System with HybridAPC ProbeErbe USA, Inc. · 2015 · cites it directly12descendants
- K171158Single Use Electrosurgical knifeOlympus Medical Systems Corp. · 2017 · cites it directly7descendants
- K243120HybridAPC probeErbe Elektromedizin GmbH · 2025 · 2 generations on1descendant
- K231023ERBEJET® 2 SystemErbe Elektromedizin GmbH · 2023 · 2 generations on1descendant
- K193601Single Use Electrosurgical KnifeMicro-Tech (Nanjing) Co., Ltd. · 2020 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K952726 | Ultracision Harmonic Scapel | Ultracision, Inc. | 1995 | — |
| −5 | K990430 | Ultracision Harmonic Scalpel Hand Piece | Ethicon Endo-Surgery, Inc. | 1999 | — |
| −4 | K012464 | Helix Hydro-Jet | Andreas Pein Medizintechnik GmbH | 2001 | — |
| −3 | K022613 | Helix Hydro-Jet | Erbe USA, Inc. | 2002 | — |
| −2 | K033590 | Erbe Helix Hydro-Jet | Erbe USA, Inc. | 2004 | — |
| −1 | K062712 | Erbe Monopolar Attachment for Helix Hydro-Jet, Model P/N 20139-094 | Erbe USA, Inc. | 2007 | — |
| 0 (this device) | K083608 | Erbe Hybrid Knife | Erbe USA, Inc. | 2009 | — |
| +1 | K143306 | ERBE WaterJet Model ERBEJET® 2 System with HybridAPC Probe | Erbe USA, Inc. | 2015 | — |
| +1 | K171158 | Single Use Electrosurgical knife | Olympus Medical Systems Corp. | 2017 | 2 |
| +2 | K243120 | HybridAPC probe | Erbe Elektromedizin GmbH | 2025 | — |
| +2 | K231023 | ERBEJET® 2 System | Erbe Elektromedizin GmbH | 2023 | — |
| +2 | K193601 | Single Use Electrosurgical Knife | Micro-Tech (Nanjing) Co., Ltd. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 4 | 0 |
| 1995 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 2 | 0 |
| 2002 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 3 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2025 | 3 | 0 |
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 K231790 The InMode System with the Morpheus8 Applicatorsscore 32.7 · 21 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K062712 | Erbe Monopolar Attachment for Helix Hydro-Jet, Model P/N 20139-094Summary page 1…oduct Code: FQH and GEl Leqally Marketed Predicate Device: ERBE Monopolar Attachment for Helix Hydro-Jet 510(k) Number: K062712 and ERBE ERBEJET 2 System (Includes Applicator) 510(k) Number: K072404 Device Description: The ERBE… | 2007 |
| * | K072404 | Erbe Erbejet 2 SystemSummary page 1…ttachment for Helix Hydro-Jet 510(k) Number: K062712 and ERBE ERBEJET 2 System (Includes Applicator) 510(k) Number: K072404 Device Description: The ERBE Hybrid Knife T M is used with the Water Jet Model ERBEJET-® 2 and an ERBE ElectroSurgical Unit (ES… | 2007 |
What descends from it? (13)
See all 134 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 14 years and passes through 4 companies; a new generation was cleared every 2.6 years on median.
- 2 of the 19 ancestors have a recall of any class.
- Of its descendants, K143306 (Erbe USA, Inc., 2015) has gone furthest, with 12 descendants of its own.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · GEI
52in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GEI
113in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GEI
4in 2025
Class I (14 since 2007) Class II/III not classified
Adverse event reports per year · GEI
7,592in 2025
MAUDE reports naming product code GEI, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 50 | 51 | 21 | 2,795 |
| 2008 | 61 | 71 | 19 | 2,556 |
| 2009 | 42 | 130 | 27 | 3,591 |
| 2010 | 46 | 109 | 51 | 3,377 |
| 2011 | 35 | 135 | 32 | 4,463 |
| 2012 | 39 | 133 | 30 | 5,216 |
| 2013 | 48 | 136 | 13 | 4,897 |
| 2014 | 49 | 103 | 3 | 4,908 |
| 2015 | 47 | 123 | 4 | 4,936 |
| 2016 | 64 | 108 | 3 | 5,616 |
| 2017 | 52 | 72 | 2 | 6,073 |
| 2018 | 47 | 93 | 6 | 6,545 |
| 2019 | 48 | 93 | 5 | 7,067 |
| 2020 | 59 | 105 | 1 | 6,490 |
| 2021 | 46 | 146 | 6 | 6,354 |
| 2022 | 55 | 150 | 49 | 6,103 |
| 2023 | 65 | 104 | 27 (4) | 7,176 |
| 2024 | 59 | 125 | 22 (10) | 7,897 |
| 2025 | 52 | 113 | 4 | 7,592 |
| 2026 | 43 | 183 | 8 | — |
What is it indicated for?
The ERBE Hybrid KnifeTM is intended to be used in combination with the Water Jet System/ERBEJET 2 and an ERBE ESU VIO Model to cut and dissect soft tissue in neurosurgery and soft tissue such as the liver, kidney, etc. within the abdomen, including Total Mesorectal Excision (TME) via the Water Jet System as well as to provide monopolar cutting and coagulation of the target tissue by the ESU in open and as well as endoscopic surgery.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083608 · printed Nov 6, 2026
Cite this page
510(k) Report. “K083608: Erbe Hybrid Knife.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K083608
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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