# K180200: ESG-300, APU-300, Pressure Reducer, MAPC Probes

- Pathway: 510(k) (Traditional)
- Applicant: Olympus Winter & Ibe GmbH
- Decided: Apr 26, 2018 after 92 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 K911904 (1991). 21 ancestors in all.
No later device cites it as a predicate yet.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141225: Esg-400, Footswitch Double Pedal, Footswitch Single Pedal, P-Cord, Olympus Winter & Ibe GmbH (2014) Summary page 4.
- K083452: Erbe Model Vio 300 D with Accessories, Erbe USA, Inc. (2008) Summary page 5.
- K024047: Erbe Vio Apc with Accessories, Erbe USA, Inc. (2003) Summary page 5.
- K060183: Erbe Apc Integrated Filter Probes; Erbe Apc Integrated Filter Probe Adapter, Erbe USA, Inc. (2006) Summary page 5.

## Indications for use
ESG-300: The electrosurgical generator ESG-300, in conjunction with electrosurgical accessories and ancillary equipment, is intended for cutting and coagulation of tissue in open surgery, laparoscopic surgery and endoscopic surgery. For monopolar argon plasma coagulation (MAPC) of tissue, the electrosurgical generator is intended to be used with a compatible Olympus argon plasma coagulation unit to deliver ionized argon gas. Accessories: APU-300: The argon plasma coagulation unit and its accessories, in conjunction with a compatible Olympus electrosurgical generator and monopolar argon plasma coagulation (MAPC) probes, are intended to deliver ionized argon gas for monopolar argon plasma coagulation of tissue. Pressure Reducer (accessory of APU-300): The pressure reducers are accessories and must only be used in conjunction with the compatible argon plasma coagulation unit APU-300. Observe the instructions for use of the compatible argon plasma coagulation unit APU-300 regarding: intended use/ contraindications/ user qualifications/ environment of use/ compatible equipment MAPC probes: The single use and flexible monopolar argon plasma coagulation probes, in conjunction with a compatible Olympus argon plasma coagulation unit and a compatible Olympus electrosurgical generator, are intended to deliver ionized argon gas for monopolar argon plasma coagulation of tissue.

Source page: https://510kreport.com/device/K180200
Methodology: https://510kreport.com/methodology