510(k) · Cleared
ClearedERBE WaterJet Model ERBEJET® 2 System with HybridAPC Probe
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 Oct 27, 2015 as substantially equivalent to K072404 (Erbe USA, Inc., 2007) and 3 other predicates after a 343-day review. Its family tree reaches back 7 generations to 1995. 12 later devices descend from it.
- Decided
- Oct 27, 2015
- Review
- 343 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 7 generations to K952726 (1995). 29 ancestors in all, the oldest K894762 (1989). 12 later devices descend from it, 3 citing it directly.
- Root · 7 generations backK952726 Ultracision Harmonic ScapelUltracision, Inc. · 1995
- 6 generations backK990430 Ultracision Harmonic Scalpel Hand PieceEthicon Endo-Surgery, Inc. · 1999
- 5 generations backK012464 Helix Hydro-JetAndreas Pein Medizintechnik GmbH · 2001
- 4 generations backK022613 Helix Hydro-JetErbe USA, Inc. · 2002
- 3 generations backK033590 Erbe Helix Hydro-JetErbe USA, Inc. · 2004
- 2 generations backK062712 Erbe Monopolar Attachment for Helix Hydro-Jet, Model P/N 20139-094Erbe USA, Inc. · 2007
- 1 generation backK083608 Erbe Hybrid KnifeErbe USA, Inc. · 2009
- This deviceK143306 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 · cites it directly · 1 of its ownK243120 HybridAPC probeErbe Elektromedizin GmbH · 2025
- Descendant · cites it directly · 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
- Descendant · 2 generations on · 1 of its ownK182408 Single Use Electrosurgical Knife KD-625 , Single Use Electrosurgical…Olympus Medical Systems Corp. · 2019 · Recalled
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K171158Single Use Electrosurgical knifeOlympus Medical Systems Corp. · 2017 · cites it directly7descendants
- K243120HybridAPC probeErbe Elektromedizin GmbH · 2025 · cites it directly1descendant
- K231023ERBEJET® 2 SystemErbe Elektromedizin GmbH · 2023 · cites it directly1descendant
- K193601Single Use Electrosurgical KnifeMicro-Tech (Nanjing) Co., Ltd. · 2020 · 2 generations on1descendant
- K182408Single Use Electrosurgical Knife KD-625 , Single Use Electrosurgical Knife KD-645Olympus Medical Systems Corp. · 2019 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K952726 | Ultracision Harmonic Scapel | Ultracision, Inc. | 1995 | — |
| −6 | K990430 | Ultracision Harmonic Scalpel Hand Piece | Ethicon Endo-Surgery, Inc. | 1999 | — |
| −5 | K012464 | Helix Hydro-Jet | Andreas Pein Medizintechnik GmbH | 2001 | — |
| −4 | K022613 | Helix Hydro-Jet | Erbe USA, Inc. | 2002 | — |
| −3 | K033590 | Erbe Helix Hydro-Jet | Erbe USA, Inc. | 2004 | — |
| −2 | K062712 | Erbe Monopolar Attachment for Helix Hydro-Jet, Model P/N 20139-094 | Erbe USA, Inc. | 2007 | — |
| −1 | K083608 | Erbe Hybrid Knife | Erbe USA, Inc. | 2009 | — |
| 0 (this device) | 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 |
| +1 | K243120 | HybridAPC probe | Erbe Elektromedizin GmbH | 2025 | — |
| +1 | K231023 | ERBEJET® 2 System | Erbe Elektromedizin GmbH | 2023 | — |
| +2 | K193601 | Single Use Electrosurgical Knife | Micro-Tech (Nanjing) Co., Ltd. | 2020 | — |
| +2 | K182408 | Single Use Electrosurgical Knife KD-625 , Single Use Electrosurgical Knife… | Olympus Medical Systems Corp. | 2019 | 3 |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (4)
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 |
|---|---|---|---|
| * | K072404 | Erbe Erbejet 2 SystemSummary page 4…Lavage (21 CFR Part 880.5475) Product Code: GEI and FQH Legally Marketed Predicate Device: ERBEJET® 2 System, 510(k) Number K072404 ERBELIFT™ Hand Pump and Flexible Probe, 510(k) Number… | 2007 |
| * | K092090 | Erbelift Hand Pump and Flexible ProbeSummary page 4…RBEJET® 2 System, 510(k) Number K072404 ERBELIFT™ Hand Pump and Flexible Probe, 510(k) Number K092090 ERBE Hybrid Knife™, 510(k) Number K083608 ERBE APC In… | 2009 |
| * | K083608 | Erbe Hybrid KnifeSummary page 4…BELIFT™ Hand Pump and Flexible Probe, 510(k) Number K092090 ERBE Hybrid Knife™, 510(k) Number K083608 ERBE APC Integrated Filter Probes (FiAPC Probes) with… | 2009 |
| * | K060183 | Erbe Apc Integrated Filter Probes; Erbe Apc Integrated Filter Probe AdapterSummary page 4…) Number K083608 ERBE APC Integrated Filter Probes (FiAPC Probes) with Adaptor, 510(k) Number K060183 Note: The only change to the current ERBEJET 2 System is the addition of lifting mucosal lesions by injection into the submucos… | 2006 |
What descends from it? (12)
See all 123 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 20 years and passes through 4 companies; a new generation was cleared every 2.6 years on median.
- 2 of the 29 ancestors have a recall of any class.
- Of its descendants, K171158 (Olympus Medical Systems Corp., 2017) has gone furthest, with 7 descendants of its own.
- 2 other devices also cite its predicate K072404.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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?
ERBEJET® 2 System
The ERBEJET 2 is intended for lifting mucosal lesions by injection into the submucosa as well as the cutting and dissection of soft tissue in neurosurgery and soft tissue such as the liver, kidney, etc. within the abdomen, including Total Mesorectal Excision (TME) in open as well as endoscopic surgery.
HybridAPC Probe
The HybridAPC probe is indicated for the induction of sterile normal saline into the submucosa to lift mucosal lesions using direct visualization through an endoscope and for HF ablation of the mucosal lesion by Argon Plasma Coagulation (APC).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K143306 · printed Nov 6, 2026
Cite this page
510(k) Report. “K143306: ERBE WaterJet Model ERBEJET® 2 System with HybridAPC Probe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K143306
Report an extraction error
Are you the manufacturer?
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