# K083608: Erbe Hybrid Knife

- Pathway: 510(k) (Traditional)
- Applicant: Erbe USA, Inc.
- Decided: Aug 26, 2009 after 264 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: 6 generations back to K952726 (1995). 19 ancestors in all.
13 later devices descend from it; 4 cite it directly.
0 of 33 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062712: Erbe Monopolar Attachment for Helix Hydro-Jet, Model P/N 20139-094, Erbe USA, Inc. (2007) Summary page 1.
- K072404: Erbe Erbejet 2 System, Erbe USA, Inc. (2007) Summary page 1.

## Most influential descendants
- 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
- K193601: Single Use Electrosurgical Knife (2020), 1 descendant of its own

## Indications for use
The ERBE Hybrid KnifeTM is intended to be used in combination with the Water Jet System/ERBEJET 2 and an ERBE ESU VIO Model to cut and dissect soft tissue in neurosurgery and soft tissue such as the liver, kidney, etc. within the abdomen, including Total Mesorectal Excision (TME) via the Water Jet System as well as to provide monopolar cutting and coagulation of the target tissue by the ESU in open and as well as endoscopic surgery.

Source page: https://510kreport.com/device/K083608
Methodology: https://510kreport.com/methodology