Medical Device Manufacturer · US , Lawrenceville , GA

Erbe USA, Inc.

39 submissions · 39 cleared · Since 1994
39
Total
39
Cleared
0
Denied

Erbe USA, Inc. — FDA 510(k) Submissions

Erbe USA, Inc. has submitted 39 FDA 510(k) premarket notifications since 1994, of which 39 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Electrosurgical, Cutting & Coagulation & Accessories, Endoscopic Irrigation/suction System, Lavage, Jet, Pump, Air, Non-manual, For Endoscope, Unit, Cryosurgical, Accessories . Use the specialty filter in the sidebar to narrow results.

39 devices
1–25 of 39
Erbe's Tubing/Cap Sets
K221177 · OCX Endoscopic... · Gastroenterology & Urology
Aug 2022 108d
ERBEFLO 2 Endo Quick Connect Pentax Scope Port Connector
K191438 · OCX Endoscopic... · Gastroenterology & Urology
Jun 2019 28d
ERBEFLO 2 Disposable Tubing System
K190469 · OCX Endoscopic... · Gastroenterology & Urology
May 2019 86d
ERBEFLO Olympus Scope Port Connector
K182444 · OCX Endoscopic... · Gastroenterology & Urology
Nov 2018 60d
Erbe?s CO2 Tubing/Cap Sets
K162152 · FEQ Pump, Air, Non-manual,... · Gastroenterology & Urology
Aug 2016 29d
ERBE WaterJet Model ERBEJET? 2 System with HybridAPC Probe
K143306 · GEI Electrosurgical, Cutting... · General & Plastic Surgery
Oct 2015 343d
ERBECRYO 2 Cryosurgical Unit with accessories
K151041 · GEH Unit, Cryosurgical,... · General & Plastic Surgery
May 2015 14d
Endo Quickconnect Olympus Scope Port Connector, Endo Quickconnect Pentax Scope Port Connector
K143186 · OCX Endoscopic... · Gastroenterology & Urology
Dec 2014 43d
ERBEFLO CLEVERCAP HYBRID TUBING/CAP SET FOR PENTAX SCOPES, ERBEFLO CLEVERCAP HYBRID CO2 TUBING/CAP SET FOR OLYMPUS 160/1
K132340 · FEQ Pump, Air, Non-manual,... · Gastroenterology & Urology
Dec 2013 144d
ERBE ESU MODEL VIO DV WITH ACCESSORIES
K133180 · GEI Electrosurgical, Cutting... · General & Plastic Surgery
Dec 2013 55d
ERBEFLO CLEVERCAP HYBRID TUBING/CAP SETS FOR OLYMPUS MODELS 160 AND 180 SERIES SCOPES
K103696 · FEQ Pump, Air, Non-manual,... · Gastroenterology & Urology
Mar 2011 95d
ERBEFLO 2 DISPOSABLE TUBING SYSTEM
K103235 · OCX Endoscopic... · Gastroenterology & Urology
Dec 2010 51d
ERBE ESU MODEL VIO 100 C WITH ACCESSORIES
K101108 · GEI Electrosurgical, Cutting... · General & Plastic Surgery
Jul 2010 87d
ERBE HYBRID KNIFE
K083608 · GEI Electrosurgical, Cutting... · General & Plastic Surgery
Aug 2009 264d
ERBE MODEL VIO 300 D WITH ACCESSORIES
K083452 · GEI Electrosurgical, Cutting... · General & Plastic Surgery
Dec 2008 40d
ERBE VIO ESU, MODEL VIO 200 S
K080715 · GEI Electrosurgical, Cutting... · General & Plastic Surgery
Apr 2008 20d
ERBE ERBEJET 2 SYSTEM
K072404 · FQH Lavage, Jet · General Hospital
Oct 2007 65d
ERBE MONOPOLAR ATTACHMENT FOR HELIX HYDRO-JET, MODEL P/N 20139-094
K062712 · GEI Electrosurgical, Cutting... · General & Plastic Surgery
Jan 2007 137d
ERBE VIO ESU, MODEL VIO 300 D
K060484 · GEI Electrosurgical, Cutting... · General & Plastic Surgery
Mar 2006 20d
ERBE BICLAMP OPEN AND LAPAROSCOPIC INSTRUMENTS
K060170 · GEI Electrosurgical, Cutting... · General & Plastic Surgery
Feb 2006 24d
ERBE APC INTEGRATED FILTER PROBES; ERBE APC INTEGRATED FILTER PROBE ADAPTER
K060183 · GEI Electrosurgical, Cutting... · General & Plastic Surgery
Feb 2006 23d
ERBE ERBOKRYO CA CRYOSURGICAL UNIT & ACCESSORIES
K051509 · GEH Unit, Cryosurgical,... · General & Plastic Surgery
Jul 2005 50d
ERBE BICLAMP OPEN AND LAPAROSCOPIC INSTRUMENTS
K033421 · GEI Electrosurgical, Cutting... · General & Plastic Surgery
Oct 2004 353d
ERBE HELIX HYDRO-JET
K033590 · FQH Lavage, Jet · General Hospital
Jan 2004 81d
ERBE VIO APC WITH ACCESSORIES
K024047 · GEI Electrosurgical, Cutting... · General & Plastic Surgery
Jan 2003 30d
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