Erbe USA Inc
Marietta, GA, US
ERBE USA, INC. appears in FDA device records in Marietta, GA. FDA records list 39 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 4 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 39 510(k) clearances for Erbe USA Inc between 1994 and 2022. The busiest year on record is 1994, with 3. The most recent is 2022, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1994 | 3 |
| 1995 | 1 |
| 1996 | 2 |
| 1997 | 1 |
| 1999 | 2 |
| 2001 | 2 |
| 2002 | 3 |
| 2003 | 1 |
| 2004 | 2 |
| 2005 | 1 |
| 2006 | 3 |
| 2007 | 2 |
| 2008 | 2 |
| 2009 | 1 |
| 2010 | 2 |
| 2011 | 1 |
| 2013 | 2 |
| 2014 | 1 |
| 2015 | 2 |
| 2016 | 1 |
| 2018 | 1 |
| 2019 | 2 |
| 2022 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K221177 | Erbe's Tubing/Cap Sets | OCX | Substantially Equivalent | |
| K191438 | ERBEFLO 2 Endo Quick Connect Pentax Scope Port Connector | OCX | Substantially Equivalent | |
| K190469 | ERBEFLO 2 Disposable Tubing System | OCX | Substantially Equivalent | |
| K182444 | ERBEFLO Olympus Scope Port Connector | OCX | Substantially Equivalent | |
| K162152 | Erbe’s CO2 Tubing/Cap Sets | FEQ | Substantially Equivalent | |
| K143306 | ERBE WaterJet Model ERBEJET® 2 System with HybridAPC Probe | GEI | Substantially Equivalent | |
| K151041 | ERBECRYO 2 Cryosurgical Unit with accessories | GEH | Substantially Equivalent | |
| K143186 | Endo Quickconnect Olympus Scope Port Connector, Endo Quickconnect Pentax Scope Port Connector | OCX | Substantially Equivalent | |
| K132340 | ERBEFLO CLEVERCAP HYBRID TUBING/CAP SET FOR PENTAX SCOPES, ERBEFLO CLEVERCAP HYBRID CO2 TUBING/CAP SET FOR OLYMPUS 160/1 | FEQ | Substantially Equivalent | |
| K133180 | ERBE ESU MODEL VIO DV WITH ACCESSORIES | GEI | Substantially Equivalent | |
| K103696 | ERBEFLO CLEVERCAP HYBRID TUBING/CAP SETS FOR OLYMPUS MODELS 160 AND 180 SERIES SCOPES | FEQ | Substantially Equivalent | |
| K103235 | ERBEFLO 2 DISPOSABLE TUBING SYSTEM | OCX | Substantially Equivalent | |
| K101108 | ERBE ESU MODEL VIO 100 C WITH ACCESSORIES | GEI | Substantially Equivalent | |
| K083608 | ERBE HYBRID KNIFE | GEI | Substantially Equivalent | |
| K083452 | ERBE MODEL VIO 300 D WITH ACCESSORIES | GEI | Substantially Equivalent | |
| K080715 | ERBE VIO ESU, MODEL VIO 200 S | GEI | Substantially Equivalent | |
| K072404 | ERBE ERBEJET 2 SYSTEM | FQH | Substantially Equivalent | |
| K062712 | ERBE MONOPOLAR ATTACHMENT FOR HELIX HYDRO-JET, MODEL P/N 20139-094 | GEI | Substantially Equivalent | |
| K060484 | ERBE VIO ESU, MODEL VIO 300 D | GEI | Substantially Equivalent | |
| K060183 | ERBE APC INTEGRATED FILTER PROBES; ERBE APC INTEGRATED FILTER PROBE ADAPTER | GEI | Substantially Equivalent | |
| K060170 | ERBE BICLAMP OPEN AND LAPAROSCOPIC INSTRUMENTS | GEI | Substantially Equivalent | |
| K051509 | ERBE ERBOKRYO CA CRYOSURGICAL UNIT & ACCESSORIES | GEH | Substantially Equivalent | |
| K033421 | ERBE BICLAMP OPEN AND LAPAROSCOPIC INSTRUMENTS | GEI | Substantially Equivalent | |
| K033590 | ERBE HELIX HYDRO-JET | FQH | Substantially Equivalent | |
| K024047 | ERBE VIO APC WITH ACCESSORIES | GEI | Substantially Equivalent | |
| K023886 | ERBE VIO ESU WITH ACCESSORIES, MODEL VIO 300 D | GEI | Substantially Equivalent | |
| K023812 | NESSY (OMEGA) DISPOSABLE SPLIT RETURN ELECTRODES, MODELS P/N: 20193-084 AND P/N: 20193-085 | GEI | Substantially Equivalent | |
| K022613 | HELIX HYDRO-JET | FQH | Substantially Equivalent | |
| K013348 | MODIFICATION TO: ERBE APC CONNECTOR HOSE AND PROBES, MODELS 20132-158, 20132-155, 20132-156, 20132-157, 20132-166 | GEI | Substantially Equivalent | |
| K003462 | ERBE APC HANDLE AND APPLICATORS, MODEL 20132-043,20132-031,20132-032,20132-033,20132-034,20132-040,20132-044,20132-045 | GEI | Substantially Equivalent | |
| K992769 | ERBE APC APPLICATORS, MODELS 20132-106, 20132-107, 20132-109, 20132-110, 20132-11, 20132-112,20132-113, 20132-114, 2013- | GEI | Substantially Equivalent | |
| K992764 | ERBE APC RASPATORY HANDLE AND TIP, MODEL 20132-102, 20132-103 | GEI | Substantially Equivalent | |
| K972269 | DISPOSABLE PATIENT RETURN ELECTRODE | GEI | Substantially Equivalent | |
| K963189 | ERBE APC 300 ARGON PLASMA COAGULATOR AND ACCESSORIES - ARGON PLASMA COAGULATOR AND ACCESSORIES | GEI | Substantially Equivalent | |
| K960569 | DISPOSABLE PATIENT RETURN ELECTRODE | GEI | Substantially Equivalent | |
| K953159 | ERBOTOM ICC BIPOLAR | GEI | Substantially Equivalent | |
| K935815 | ERBOTOM ICC 50 | GEI | Substantially Equivalent | |
| K933002 | ERBOTOM ICC 350 | GEI | Substantially Equivalent | |
| K933157 | ERBOTOM ICC 200 | GEI | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1057212 | 1000140388 | ERBE USA, INC. | 2225 NORTHWEST PARKWAY, Marietta, GA 30067 US | 2026 | No device listings on this registration |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2938-2026 | ERBECRYO 2 Cryosurgical Unit Model/Catalog Number: 10402-000 | A strong pull on the high-pressure transfer hose of cryosurgical unit may lead to pneumatic short circuit between he gas inlet and the connector resulting in CO2 leaking into the return path, leading to excessive pressure causing the cryoprobe to rupture. | Class II | Open, Classified | |
| Z-1568-2026 | Flexible Cryoprobe (OD 2.4mm, L1.15mm) REF: 20402-411. For surgical use | Probes may rupture/burst during activation | Class I | Open, Classified | |
| Z-1567-2026 | Flexible Cryoprobe (OD 1.7mm, L1.15mm) REF: 20402-410. For surgical use | Probes may rupture/burst during activation | Class I | Open, Classified | |
| Z-1566-2026 | Flexible Cryoprobe (OD 1.1mm, L1.15mm) w/ oversheath (OD2.6mm, L817mm) REF: 20402-401 STERILE EO. For surgical use | Probes may rupture/burst during activation | Class I | Open, Classified |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain