Erbe USA, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
39
Inspections
1
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K221177Erbe's Tubing/Cap SetsAugust 11, 2022
K191438ERBEFLO 2 Endo Quick Connect Pentax Scope Port ConnectorJune 27, 2019
K190469ERBEFLO 2 Disposable Tubing SystemMay 23, 2019
K182444ERBEFLO Olympus Scope Port ConnectorNovember 6, 2018
K162152Erbe’s CO2 Tubing/Cap SetsAugust 31, 2016
K143306ERBE WaterJet Model ERBEJET® 2 System with HybridAPC ProbeOctober 27, 2015
K151041ERBECRYO 2 Cryosurgical Unit with accessoriesMay 4, 2015
K143186Endo Quickconnect Olympus Scope Port Connector, Endo Quickconnect Pentax Scope Port ConnectorDecember 18, 2014
K132340ERBEFLO CLEVERCAP HYBRID TUBING/CAP SET FOR PENTAX SCOPES, ERBEFLO CLEVERCAP HYBRID CO2 TUBING/CAP SDecember 17, 2013
K133180ERBE ESU MODEL VIO DV WITH ACCESSORIESDecember 11, 2013
K103696ERBEFLO CLEVERCAP HYBRID TUBING/CAP SETS FOR OLYMPUS MODELS 160 AND 180 SERIES SCOPESMarch 22, 2011
K103235ERBEFLO 2 DISPOSABLE TUBING SYSTEMDecember 23, 2010
K101108ERBE ESU MODEL VIO 100 C WITH ACCESSORIESJuly 16, 2010
K083608ERBE HYBRID KNIFEAugust 26, 2009
K083452ERBE MODEL VIO 300 D WITH ACCESSORIESDecember 31, 2008
K080715ERBE VIO ESU, MODEL VIO 200 SApril 2, 2008
K072404ERBE ERBEJET 2 SYSTEMOctober 31, 2007
K062712ERBE MONOPOLAR ATTACHMENT FOR HELIX HYDRO-JET, MODEL P/N 20139-094January 26, 2007
K060484ERBE VIO ESU, MODEL VIO 300 DMarch 16, 2006
K060170ERBE BICLAMP OPEN AND LAPAROSCOPIC INSTRUMENTSFebruary 16, 2006