# K012464: Helix Hydro-Jet

- Pathway: 510(k) (Abbreviated)
- Applicant: Andreas Pein Medizintechnik GmbH
- Decided: Oct 10, 2001 after 70 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: 2 generations back to K952726 (1995). 6 ancestors in all.
19 later devices descend from it; 3 cite it directly.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K982266: Hydrocision Arthrojet System, Hydrocision, Inc. (1998) Summary page 2.
- K991383: Hydrocision Debdridement System, Hydrocision, Inc. (2000) Summary page 2.
- K993564: Possis Angiojet X-Stream Rheolytic Thrombectomy Catheter, Model 103587-002, Possis Medical, Inc. (2000) Summary page 2.
- K990430: Ultracision Harmonic Scalpel Hand Piece, Ethicon Endo-Surgery, Inc. (1999) Summary page 2.

## Most influential descendants
- K022613: Helix Hydro-Jet (2002), 17 descendants of its own
- 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

## Indications for use
The Helix Hydro-Jet is intended for cutting and dissection of soft tissue such as liver and kidney in open abdominal surgery.

Source page: https://510kreport.com/device/K012464
Methodology: https://510kreport.com/methodology