510(k) · Cleared
ClearedHYBRIDknife® flex
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Erbe Elektromedizin GmbH · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Nov 29, 2023 as substantially equivalent to K083608 (Erbe USA, Inc., 2009) and 1 other predicate after a 145-day review. Its family tree reaches back 9 generations to 1995.
- Decided
- Nov 29, 2023
- Review
- 145 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 9 generations to K952726 (1995). 31 ancestors in all, the oldest K894762 (1989). No later device cites it as a predicate yet.
- Root · 9 generations backK952726 Ultracision Harmonic ScapelUltracision, Inc. · 1995
- 5 generations between
- 3 generations backK083608 Erbe Hybrid KnifeErbe USA, Inc. · 2009
- 2 generations backK143306 ERBE WaterJet Model ERBEJET® 2 System with HybridAPC ProbeErbe USA, Inc. · 2015
- 1 generation backK231023 ERBEJET® 2 SystemErbe Elektromedizin GmbH · 2023
- This deviceK232033 HYBRIDknife® flexErbe Elektromedizin GmbH · 2023
Show all 9 generations
- Root · 9 generations backK952726 Ultracision Harmonic ScapelUltracision, Inc. · 1995
- 8 generations backK990430 Ultracision Harmonic Scalpel Hand PieceEthicon Endo-Surgery, Inc. · 1999
- 7 generations backK012464 Helix Hydro-JetAndreas Pein Medizintechnik GmbH · 2001
- 6 generations backK022613 Helix Hydro-JetErbe USA, Inc. · 2002
- 5 generations backK033590 Erbe Helix Hydro-JetErbe USA, Inc. · 2004
- 4 generations backK062712 Erbe Monopolar Attachment for Helix Hydro-Jet, Model P/N 20139-094Erbe USA, Inc. · 2007
- 3 generations backK083608 Erbe Hybrid KnifeErbe USA, Inc. · 2009
- 2 generations backK143306 ERBE WaterJet Model ERBEJET® 2 System with HybridAPC ProbeErbe USA, Inc. · 2015
- 1 generation backK231023 ERBEJET® 2 SystemErbe Elektromedizin GmbH · 2023
- This deviceK232033 HYBRIDknife® flexErbe Elektromedizin GmbH · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K952726 | Ultracision Harmonic Scapel | Ultracision, Inc. | 1995 | — |
| −8 | K990430 | Ultracision Harmonic Scalpel Hand Piece | Ethicon Endo-Surgery, Inc. | 1999 | — |
| −7 | K012464 | Helix Hydro-Jet | Andreas Pein Medizintechnik GmbH | 2001 | — |
| −6 | K022613 | Helix Hydro-Jet | Erbe USA, Inc. | 2002 | — |
| −5 | K033590 | Erbe Helix Hydro-Jet | Erbe USA, Inc. | 2004 | — |
| −4 | K062712 | Erbe Monopolar Attachment for Helix Hydro-Jet, Model P/N 20139-094 | Erbe USA, Inc. | 2007 | — |
| −3 | K083608 | Erbe Hybrid Knife | Erbe USA, Inc. | 2009 | — |
| −2 | K143306 | ERBE WaterJet Model ERBEJET® 2 System with HybridAPC Probe | Erbe USA, Inc. | 2015 | — |
| −1 | K231023 | ERBEJET® 2 System | Erbe Elektromedizin GmbH | 2023 | — |
| 0 (this device) | K232033 | HYBRIDknife® flex | Erbe Elektromedizin GmbH | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1992 | 1 | 0 |
| 1994 | 4 | 0 |
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 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 |
|---|---|---|---|
| * | K083608 | Erbe Hybrid KnifeSummary page 4…rt 880.5475 Class: II Product Code: GEI & FQH Legally Marketed Predicate Devices Primary: ERBE Hybrid Knife - K083608 Secondary: ERBEJET® 2 System K231023… | 2009 |
| * | K231023 | ERBEJET® 2 SystemSummary page 4…GEI & FQH Legally Marketed Predicate Devices Primary: ERBE Hybrid Knife - K083608 Secondary: ERBEJET® 2 System K231023 Page 1 of 6 Erbe Elektromedizin… | 2023 |
What descends from it?
No later submission names this one as a predicate yet.
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 28 years and passes through 5 companies; a new generation was cleared every 2.6 years on median.
- 2 of the 31 ancestors have a recall of any class.
- 3 other devices also cite its predicate K083608.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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 HYBRIDknife flex is intended for:
• monopolar cutting and coagulation.
• needle-free injection and tissue-selective hydrodissection including lifting mucosal lesions by injection into the submucosa (soft tissue).
The HYBRIDknife flex is used in endoscopic interventions.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K232033 · printed Nov 4, 2026
Cite this page
510(k) Report. “K232033: HYBRIDknife® flex.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K232033
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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