# K935815: Erbotom Icc 50

- Pathway: 510(k) (Traditional)
- Applicant: Erbe USA, Inc.
- Decided: Mar 31, 1994 after 119 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
No predicates in its family tree.
15 later devices descend from it; 1 cites it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- 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
- K171158: Single Use Electrosurgical knife (2017), 7 descendants of its own
- K243120: HybridAPC probe (2025), 1 descendant of its own

Source page: https://510kreport.com/device/K935815
Methodology: https://510kreport.com/methodology