# K183445: Erbe APCapplicators

- Pathway: 510(k) (Traditional)
- Applicant: Erbe Elektromedizin GmbH
- Decided: Apr 4, 2019 after 113 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: 1 generation back to K003462 (2001). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003462: Erbe Apc Handle and Applicators, Model 20132-043,20132-031,20132-032,20132-033,20132-034,20132-040,20132-044,20132-045, Erbe USA, Inc. (2001) Summary page 4.

## Indications for use
Product Number (P/N) 20132-250, 20132-251, 20132-252, 20132-253, 20132-254 and 20132-255: The Rigid Argon Plasma Coagulation Applicators are intended for monopolar cutting and coagulation of tissue with and without argon gas or for coagulation and ablation using argon plasma. They are used in open and in laparoscopic surgery. P/N 20132-256: The Rigid Argon Plasma Coagulation Applicator is intended for monopolar coagulation and ablation of tissue using argon plasma. It is used in open surgical procedures.

Source page: https://510kreport.com/device/K183445
Methodology: https://510kreport.com/methodology