# Erbe USA, Inc.

- Location (FDA's records): Marietta, GA
- FDA decisions: 39 (1994–2022): 39 510(k) clearances
- Product codes: GEI (25), OCX (6), FEQ (3), FQH (3), GEH (2)
- 510(k) review time since 2016: median 60 days, against 84 for FDA's reviews in the same codes and years (2 of 5 faster)
- Predicates its devices cite: 55 (37 its own); citations of its devices by later devices: 104 (37 its own)
- Recalls linked to its devices: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Beacon Laboratories, Inc.: 4 (https://510kreport.com/company/beacon-laboratories)
- Byrne Medical, Inc.: 4 (https://510kreport.com/company/byrne-medical)
- Valleylab, Inc.: 3 (https://510kreport.com/company/valleylab)
- Andreas Pein Medizintechnik GmbH: 2 (https://510kreport.com/company/andreas-pein-medizintechnik)
- Erbe Elektromedizin GmbH: 1 (https://510kreport.com/company/erbe-elektromedizin)
- Everest Medical Corp.: 1 (https://510kreport.com/company/everest-medical)
- Erbe Electromedizin GmbH: 1 (https://510kreport.com/company/erbe-electromedizin)
- E & M Engineering, Inc.: 1 (https://510kreport.com/company/e-m-engineering)

## Firms that cite its devices most
- Erbe Elektromedizin GmbH: 14 (https://510kreport.com/company/erbe-elektromedizin)
- KLS-Martin L.P.: 6 (https://510kreport.com/company/kls-martin)
- Olympus Winter & Ibe GmbH: 5 (https://510kreport.com/company/olympus-winter-ibe)
- Conmed Corporation: 4 (https://510kreport.com/company/conmed)
- Us Medical Innovations, LLC: 4 (https://510kreport.com/company/us-medical-innovations)
- Olympus Shirakawa Co., Ltd.: 3 (https://510kreport.com/company/olympus-shirakawa)
- Genii, Inc.: 3 (https://510kreport.com/company/genii)
- Ellman Intl., Inc.: 2 (https://510kreport.com/company/ellman-intl)

## Its most-cited devices
- K963189: Erbe Apc 300 Argon Plasma Coagulator and Accessories - Argon Plasma Coagulator and Accessories (1996), cited by 10
- K083452: Erbe Model Vio 300 D with Accessories (2008), cited by 10
- K023886: Erbe Vio Esu with Accessories, Model Vio 300 D (2002), cited by 9
- K060484: Erbe Vio Esu, Model Vio 300 D (2006), cited by 9
- K933157: Erbotom Icc 200 (1994), cited by 8
- K024047: Erbe Vio Apc with Accessories (2003), cited by 8

## Recent decisions
- K221177: Erbe's Tubing/Cap Sets (Aug 11, 2022)
- K191438: ERBEFLO 2 Endo Quick Connect Pentax Scope Port Connector (Jun 27, 2019)
- K190469: ERBEFLO 2 Disposable Tubing System (May 23, 2019)
- K182444: ERBEFLO Olympus Scope Port Connector (Nov 6, 2018)
- K162152: Erbe’s CO2 Tubing/Cap Sets (Aug 31, 2016)
- K143306: ERBE WaterJet Model ERBEJET® 2 System with HybridAPC Probe (Oct 27, 2015)
- K151041: ERBECRYO 2 Cryosurgical Unit with accessories (May 4, 2015)
- K143186: Endo Quickconnect Olympus Scope Port Connector, Endo Quickconnect Pentax Scope Port Connector (Dec 18, 2014)

Source page: https://510kreport.com/company/erbe-usa