# K933002: Erbotom Icc 350

- Pathway: 510(k) (Traditional)
- Applicant: Erbe USA, Inc.
- Decided: Mar 9, 1994 after 261 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.
160 later devices descend from it; 4 cite it directly.
0 of 161 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K023886: Erbe Vio Esu with Accessories, Model Vio 300 D (2002), 136 descendants of its own
- K060484: Erbe Vio Esu, Model Vio 300 D (2006), 115 descendants of its own
- K083452: Erbe Model Vio 300 D with Accessories (2008), 55 descendants of its own
- K990628: Gyrus Endourology System (1999), 52 descendants of its own
- K030194: Xues-41 Endoscopic Electrosurgical Unit (2003), 49 descendants of its own

Source page: https://510kreport.com/device/K933002
Methodology: https://510kreport.com/methodology