# K231023: ERBEJET® 2 System

- Pathway: 510(k) (Traditional)
- Applicant: Erbe Elektromedizin GmbH
- Decided: Jun 15, 2023 after 65 days
- Product code: FQH (Lavage, Jet)
- Device class: 2
- Regulation: 21 CFR 880.5475
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K952726 (1995). 30 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 32 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.
- K143306: ERBE WaterJet Model ERBEJET® 2 System with HybridAPC Probe, Erbe USA, Inc. (2015) Summary page 4.

## Most influential descendants
- K232033: HYBRIDknife® flex (2023), 0 descendants of its own

## Indications for use
Indications for Use - Hydrosurgical unit: The Erbe hydrosurgical unit ERBEJET 2 with instruments and accessories is intended to pressurize a medium to perform needle-free injection and tissue-selective hydrodissection of soft tissue. The Erbe hydrosurgical unit ERBEJET 2 with instruments and accessories is used in endoscopic and surgical procedures. Indications for Use - Applicators and ERBEJET probe: 20150-220: The ERBEJET probe is intended for dissection (tissue-selective hydrodissection) including separation of soft tissue in endoscopic interventions. The ERBEJET probe can be used for needle-free injection including lifting of mucosal lesions by injection into the submucosa. 20150-225: The applicator is intended for dissection (tissue-selective hydrodissection) including separation of soft tissue in open surgery. 20150-226: The applicator is intended for dissection (tissue-selective hydrodissection) including separation of soft tissue in minimal invasive surgery. The applicator can be used for needle-free injection including lifting of mucosal lesions by injection into the submucosa. 20150-230, 20150-231, 20150-239: The applicators with suction are intended for dissection (tissue-selective hydrodissection) including separation of soft tissue in open surgery. The applicators with suction can be used as well for suction when connected to an external suction module e.g. Erbe ESM 2. 20150-238: The applicator with suction is intended for dissection (tissue-selective hydrodissection) including separation of soft tissue in minimal invasive surgery. The applicator with suction can be used as well for suction when connected to an external suction module e.g. Erbe ESM 2.

Source page: https://510kreport.com/device/K231023
Methodology: https://510kreport.com/methodology