# K143306: ERBE WaterJet Model ERBEJET® 2 System with HybridAPC Probe

- Pathway: 510(k) (Traditional)
- Applicant: Erbe USA, Inc.
- Decided: Oct 27, 2015 after 343 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K952726 (1995). 29 ancestors in all.
12 later devices descend from it; 3 cite it directly.
0 of 42 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072404: Erbe Erbejet 2 System, Erbe USA, Inc. (2007) Summary page 4.
- K092090: Erbelift Hand Pump and Flexible Probe, Byrne Medical, Inc. (2009) Summary page 4.
- K083608: Erbe Hybrid Knife, Erbe USA, Inc. (2009) Summary page 4.
- K060183: Erbe Apc Integrated Filter Probes; Erbe Apc Integrated Filter Probe Adapter, Erbe USA, Inc. (2006) Summary page 4.

## Most influential descendants
- K171158: Single Use Electrosurgical knife (2017), 7 descendants of its own
- K243120: HybridAPC probe (2025), 1 descendant of its own
- K231023: ERBEJET® 2 System (2023), 1 descendant of its own
- K193601: Single Use Electrosurgical Knife (2020), 1 descendant of its own
- K182408: Single Use Electrosurgical Knife KD-625 , Single Use Electrosurgical Knife KD-645 (2019), 1 descendant of its own

## Indications for use
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).

Source page: https://510kreport.com/device/K143306
Methodology: https://510kreport.com/methodology