# K022613: Helix Hydro-Jet

- Pathway: 510(k) (Traditional)
- Applicant: Erbe USA, Inc.
- Decided: Oct 25, 2002 after 80 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: 3 generations back to K952726 (1995). 7 ancestors in all.
17 later devices descend from it; 2 cite it directly.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012464: Helix Hydro-Jet, Andreas Pein Medizintechnik GmbH (2001)

## Most influential descendants
- K033590: Erbe Helix Hydro-Jet (2004), 16 descendants of its own
- K072404: Erbe Erbejet 2 System (2007), 14 descendants of its own
- K062712: Erbe Monopolar Attachment for Helix Hydro-Jet, Model P/N 20139-094 (2007), 14 descendants of its own
- K083608: Erbe Hybrid Knife (2009), 13 descendants of its own
- K143306: ERBE WaterJet Model ERBEJET® 2 System with HybridAPC Probe (2015), 12 descendants of its own

## Indications for use
The Helix Hydro-Jet is intended for the cutting and dissection of soft tissue such as the liver, kidney, etc. within the abdomen, including Total Mesorectal Excision (TME), in open as well as laparoscopic surgery.

Source page: https://510kreport.com/device/K022613
Methodology: https://510kreport.com/methodology