Erbe USA, Inc.
Medical device manufacturer in Marietta, GA.
39510(k) clearances
0PMA approvals
4recalls
Device types
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K221177 | Erbe's Tubing/Cap SetsOCX · Traditional | 08/11/2022SE |
| K191438 | ERBEFLO 2 Endo Quick Connect Pentax Scope Port ConnectorOCX · Special | 06/27/2019SE |
| K190469 | ERBEFLO 2 Disposable Tubing SystemOCX · Traditional | 05/23/2019SE |
| K182444 | ERBEFLO Olympus Scope Port ConnectorOCX · Traditional | 11/06/2018SE |
| K162152 | Erbes CO2 Tubing/Cap SetsFEQ · Special | 08/31/2016SE |
| K143306 | ERBE WaterJet Model ERBEJET® 2 System with HybridAPC ProbeGEI · Traditional | 10/27/2015SE |
| K151041 | ERBECRYO 2 Cryosurgical Unit with accessoriesGEH · Special | 05/04/2015SE |
| K143186 | Endo Quickconnect Olympus Scope Port Connector, Endo Quickconnect Pentax Scope Port…OCX · Special | 12/18/2014SE |
| K132340 | Erbeflo Clevercap Hybrid Tubing/Cap Set for Pentax Scopes, Erbeflo Clevercap Hybrid CO2…FEQ · Traditional | 12/17/2013SE |
| K133180 | Erbe Esu Model Vio DV with AccessoriesGEI · Special | 12/11/2013SE |
| K103696 | Erbeflo Clevercap Hybrid Tubing/Cap Sets for Olympus Models 160 and 180 Series ScopesFEQ · Traditional | 03/22/2011SE |
| K103235 | Erbeflo 2 Disposable Tubing SystemOCX · Traditional | 12/23/2010SE |
| K101108 | Erbe Esu Model Vio 100 C with AccessoriesGEI · Special | 07/16/2010SE |
| K083608 | Erbe Hybrid KnifeGEI · Traditional | 08/26/2009SE |
| K083452 | Erbe Model Vio 300 D with AccessoriesGEI · Special | 12/31/2008SE |
| K080715 | Erbe Vio Esu, Model Vio 200 SGEI · Special | 04/02/2008SE |
| K072404 | Erbe Erbejet 2 SystemFQH · Abbreviated | 10/31/2007SE |
| K062712 | Erbe Monopolar Attachment for Helix Hydro-Jet, Model P/N 20139-094GEI · Traditional | 01/26/2007SE |
| K060484 | Erbe Vio Esu, Model Vio 300 DGEI · Special | 03/16/2006SE |
| K060183 | Erbe Apc Integrated Filter Probes; Erbe Apc Integrated Filter Probe AdapterGEI · Special | 02/16/2006SE |
| K060170 | Erbe Biclamp Open and Laparoscopic InstrumentsGEI · Special | 02/16/2006SE |
| K051509 | Erbe Erbokryo Ca Cryosurgical Unit & AccessoriesGEH · Traditional | 07/27/2005SE |
| K033421 | Erbe Biclamp Open and Laparoscopic InstrumentsGEI · Abbreviated | 10/14/2004SE |
| K033590 | Erbe Helix Hydro-JetFQH · Traditional | 01/30/2004SE |
| K024047 | Erbe Vio Apc with AccessoriesGEI · Special | 01/08/2003SE |
| K023886 | Erbe Vio Esu with Accessories, Model Vio 300 DGEI · Special | 12/12/2002SE |
| K023812 | Nessy (Omega) Disposable Split Return Electrodes, Models P/N: 20193-084 and P/N: 20193-085GEI · Special | 11/29/2002SE |
| K022613 | Helix Hydro-JetFQH · Traditional | 10/25/2002SE |
| K013348 | Modification to: Erbe Apc Connector Hose and Probes, Models 20132-158, 20132-155…GEI · Special | 10/26/2001SE |
| K003462 | Erbe Apc Handle and Applicators, Model 20132-043,20132-031,20132-032,20132-033,20132-034…GEI · Abbreviated | 01/04/2001SE |
| K992769 | Erbe Apc Applicators, Models 20132-106, 20132-107, 20132-109, 20132-110, 20132-11…GEI · Traditional | 10/14/1999SE |
| K992764 | Erbe Apc Raspatory Handle and Tip, Model 20132-102, 20132-103GEI · Traditional | 10/14/1999SE |
| K972269 | Disposable Patient Return ElectrodeGEI · Traditional | 07/09/1997SE |
| K963189 | Erbe Apc 300 Argon Plasma Coagulator and Accessories - Argon Plasma Coagulator and…GEI · Traditional | 11/26/1996SE |
| K960569 | Disposable Patient Return ElectrodeGEI · Traditional | 03/11/1996SE |
| K953159 | Erbotom Icc BipolarGEI · Traditional | 10/04/1995SE |
| K935815 | Erbotom Icc 50GEI · Traditional | 03/31/1994SE |
| K933002 | Erbotom Icc 350GEI · Traditional | 03/09/1994SE |
| K933157 | Erbotom Icc 200GEI · Traditional | 02/23/1994SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-2938-2026 Class II | ERBECRYO 2 Cryosurgical Unit Model/Catalog Number: 10402-000A strong pull on the high-pressure transfer hose of cryosurgical unit may lead to pneumatic short circuit… | 06/26/2026Open, Classified |
| Z-1568-2026 Class I | Flexible Cryoprobe (OD 2.4mm, L1.15mm) REF: 20402-411. For surgical useProbes may rupture/burst during activation | 02/12/2026Open, Classified |
| Z-1567-2026 Class I | Flexible Cryoprobe (OD 1.7mm, L1.15mm) REF: 20402-410. For surgical useProbes may rupture/burst during activation | 02/12/2026Open, Classified |
| Z-1566-2026 Class I | Flexible Cryoprobe (OD 1.1mm, L1.15mm) w/ oversheath (OD2.6mm, L817mm) REF: 20402-401…Probes may rupture/burst during activation | 02/12/2026Open, Classified |