# K062712: Erbe Monopolar Attachment for Helix Hydro-Jet, Model P/N 20139-094

- Pathway: 510(k) (Traditional)
- Applicant: Erbe USA, Inc.
- Decided: Jan 26, 2007 after 137 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: 5 generations back to K952726 (1995). 17 ancestors in all.
14 later devices descend 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)
- K033590: Erbe Helix Hydro-Jet, Erbe USA, Inc. (2004) Summary page 1.
- K953738: Erbotom Icc 300, Erbe Electromedizin GmbH (1995) Summary page 1.
- K953159: Erbotom Icc Bipolar, Erbe USA, Inc. (1995) Summary page 1.
- K935815: Erbotom Icc 50, Erbe USA, Inc. (1994) Summary page 1.
- K933002: Erbotom Icc 350, Erbe USA, Inc. (1994) Summary page 1.
- K933157: Erbotom Icc 200, Erbe USA, Inc. (1994) Summary page 1.
- K060484: Erbe Vio Esu, Model Vio 300 D, Erbe USA, Inc. (2006) Summary page 1.
- K936304: Electrosurgical Pencil, E & M Engineering, Inc. (1994) Summary page 1.

## Most influential descendants
- 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
- 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

## Indications for use
The Monopolar Attachment combines the use of the Helix Hydro-JetTM Applicator with suction (Part Number 20139-074) with the use of monopolar coagulation and cutting (optional drip irrigation is also available) when used in conjunction with an ERBE ESU (ICC or VIO Models). Note: The Electrosurgical Unit (ESU) to be used must have a Monopolar 3-pin bovie receptacle. The use of ERBE ESU ICC and VIO Models are recommended. Compatibility and settings should be demonstrated/established prior to using a different Generator in the clinical environment.

Source page: https://510kreport.com/device/K062712
Methodology: https://510kreport.com/methodology