Company · US
Erbe USA, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1994 to 2022. Name variants (Inc, Corp, punctuation) are merged.
39510(k) clearances (0 in 12 months)
4recalls (4 in 12 months)
4recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 11, 2022 | K221177 | Erbe's Tubing/Cap Sets Erbe USA, Inc. | OCX |
| Jun 27, 2019 | K191438 | ERBEFLO 2 Endo Quick Connect Pentax Scope Port Connector Erbe USA, Inc. | OCX |
| May 23, 2019 | K190469 | ERBEFLO 2 Disposable Tubing System Erbe USA, Inc. | OCX |
| Nov 6, 2018 | K182444 | ERBEFLO Olympus Scope Port Connector Erbe USA, Inc. | OCX |
| Aug 31, 2016 | K162152 | Erbes CO2 Tubing/Cap Sets Erbe USA, Inc. | FEQ |
| Oct 27, 2015 | K143306 | ERBE WaterJet Model ERBEJET® 2 System with HybridAPC Probe Erbe USA, Inc. | GEI |
| May 4, 2015 | K151041 | ERBECRYO 2 Cryosurgical Unit with accessories Erbe USA, Inc. | GEH |
| Dec 18, 2014 | K143186 | Endo Quickconnect Olympus Scope Port Connector, Endo Quickconnect Pentax Scope Port Connector Erbe USA, Inc. | OCX |
| Dec 17, 2013 | K132340 | ERBEFLO CLEVERCAP HYBRID TUBING/CAP SET FOR PENTAX SCOPES, ERBEFLO CLEVERCAP HYBRID CO2 TUBING/CAP SET FOR OLYMPUS 160/1 Erbe USA, Inc. | FEQ |
| Dec 11, 2013 | K133180 | ERBE ESU MODEL VIO DV WITH ACCESSORIES Erbe USA, Inc. | GEI |
| Mar 22, 2011 | K103696 | ERBEFLO CLEVERCAP HYBRID TUBING/CAP SETS FOR OLYMPUS MODELS 160 AND 180 SERIES SCOPES Erbe USA, Inc. | FEQ |
| Dec 23, 2010 | K103235 | ERBEFLO 2 DISPOSABLE TUBING SYSTEM Erbe USA, Inc. | OCX |
| Jul 16, 2010 | K101108 | ERBE ESU MODEL VIO 100 C WITH ACCESSORIES Erbe USA, Inc. | GEI |
| Aug 26, 2009 | K083608 | ERBE HYBRID KNIFE Erbe USA, Inc. | GEI |
| Dec 31, 2008 | K083452 | ERBE MODEL VIO 300 D WITH ACCESSORIES Erbe USA, Inc. | GEI |
| Apr 2, 2008 | K080715 | ERBE VIO ESU, MODEL VIO 200 S Erbe USA, Inc. | GEI |
| Oct 31, 2007 | K072404 | ERBE ERBEJET 2 SYSTEM Erbe USA, Inc. | FQH |
| Jan 26, 2007 | K062712 | ERBE MONOPOLAR ATTACHMENT FOR HELIX HYDRO-JET, MODEL P/N 20139-094 Erbe USA, Inc. | GEI |
| Mar 16, 2006 | K060484 | ERBE VIO ESU, MODEL VIO 300 D Erbe USA, Inc. | GEI |
| Feb 16, 2006 | K060183 | ERBE APC INTEGRATED FILTER PROBES; ERBE APC INTEGRATED FILTER PROBE ADAPTER Erbe USA, Inc. | GEI |
| Feb 16, 2006 | K060170 | ERBE BICLAMP OPEN AND LAPAROSCOPIC INSTRUMENTS Erbe USA, Inc. | GEI |
| Jul 27, 2005 | K051509 | ERBE ERBOKRYO CA CRYOSURGICAL UNIT & ACCESSORIES Erbe USA, Inc. | GEH |
| Oct 14, 2004 | K033421 | ERBE BICLAMP OPEN AND LAPAROSCOPIC INSTRUMENTS Erbe USA, Inc. | GEI |
| Jan 30, 2004 | K033590 | ERBE HELIX HYDRO-JET Erbe USA, Inc. | FQH |
| Jan 8, 2003 | K024047 | ERBE VIO APC WITH ACCESSORIES Erbe USA, Inc. | GEI |
| Dec 12, 2002 | K023886 | ERBE VIO ESU WITH ACCESSORIES, MODEL VIO 300 D Erbe USA, Inc. | GEI |
| Nov 29, 2002 | K023812 | NESSY (OMEGA) DISPOSABLE SPLIT RETURN ELECTRODES, MODELS P/N: 20193-084 AND P/N: 20193-085 Erbe USA, Inc. | GEI |
| Oct 25, 2002 | K022613 | HELIX HYDRO-JET Erbe USA, Inc. | FQH |
| Oct 26, 2001 | K013348 | MODIFICATION TO: ERBE APC CONNECTOR HOSE AND PROBES, MODELS 20132-158, 20132-155, 20132-156, 20132-157, 20132-166 Erbe USA, Inc. | GEI |
| Jan 4, 2001 | K003462 | ERBE APC HANDLE AND APPLICATORS, MODEL 20132-043,20132-031,20132-032,20132-033,20132-034,20132-040,20132-044,20132-045 Erbe USA, Inc. | GEI |
| Oct 14, 1999 | K992769 | ERBE APC APPLICATORS, MODELS 20132-106, 20132-107, 20132-109, 20132-110, 20132-11, 20132-112,20132-113, 20132-114, 2013- Erbe USA, Inc. | GEI |
| Oct 14, 1999 | K992764 | ERBE APC RASPATORY HANDLE AND TIP, MODEL 20132-102, 20132-103 Erbe USA, Inc. | GEI |
| Jul 9, 1997 | K972269 | DISPOSABLE PATIENT RETURN ELECTRODE Erbe USA, Inc. | GEI |
| Nov 26, 1996 | K963189 | ERBE APC 300 ARGON PLASMA COAGULATOR AND ACCESSORIES - ARGON PLASMA COAGULATOR AND ACCESSORIES Erbe USA, Inc. | GEI |
| Mar 11, 1996 | K960569 | DISPOSABLE PATIENT RETURN ELECTRODE Erbe USA, Inc. | GEI |
| Oct 4, 1995 | K953159 | ERBOTOM ICC BIPOLAR Erbe USA, Inc. | GEI |
| Mar 31, 1994 | K935815 | ERBOTOM ICC 50 Erbe USA, Inc. | GEI |
| Mar 9, 1994 | K933002 | ERBOTOM ICC 350 Erbe USA, Inc. | GEI |
| Feb 23, 1994 | K933157 | ERBOTOM ICC 200 Erbe USA, Inc. | GEI |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 12, 2026 | Erbe USA Inc ERBECRYO 2 Cryosurgical Unit
Model/Catalog Number: 10402-000 Open, Classified |
GEH | K190651 |
| Mar 20, 2026 | Erbe USA Inc Flexible Cryoprobe (OD 2.4mm, L1.15mm)
REF: 20402-411. For surgical use Open, Classified |
GEH | K190651 |
| Mar 20, 2026 | Erbe USA Inc Flexible Cryoprobe (OD 1.7mm, L1.15mm)
REF: 20402-410. For surgical use Open, Classified |
GEH | K190651 |
| Mar 20, 2026 | Erbe USA Inc Flexible Cryoprobe (OD 1.1mm, L1.15mm) w/ oversheath (OD2.6mm, L817mm)
REF: 20402-401
STERILE EO. For surgical use Open, Classified |
GEH | K190651 |