Medical Device Manufacturer · US , Orange , CA

Erbe Elektromedizin GmbH

14 submissions · 14 cleared · Since 1994
14
Total
14
Cleared
0
Denied

Erbe Elektromedizin GmbH — FDA 510(k) Submissions

Erbe Elektromedizin GmbH has submitted 14 FDA 510(k) premarket notifications since 1994, of which 14 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Electrosurgical, Cutting & Coagulation & Accessories, Unit, Cryosurgical, Accessories, Lavage, Jet . Use the specialty filter in the sidebar to narrow results.

14 devices
1–14 of 14
MOVIVA? Hybrid Ablation Probe
K253915 · GEI Electrosurgical, Cutting... · General & Plastic Surgery
Dec 2025 10d
Erbe ESU Model VIO? 3n with Accessories
K251108 · GEI Electrosurgical, Cutting... · General & Plastic Surgery
Aug 2025 140d
HybridAPC probe
K243120 · GEI Electrosurgical, Cutting... · General & Plastic Surgery
Jun 2025 263d
FiAPC plus probes
K243451 · GEI Electrosurgical, Cutting... · General & Plastic Surgery
Mar 2025 134d
FiAPC plus probes
K242044 · GEI Electrosurgical, Cutting... · General & Plastic Surgery
Aug 2024 45d
HybridTherm System
K240932 · GEI Electrosurgical, Cutting... · General & Plastic Surgery
Aug 2024 122d
HYBRIDknife? flex
K232033 · GEI Electrosurgical, Cutting... · General & Plastic Surgery
Nov 2023 145d
ERBEJET? 2 System
K231023 · FQH Lavage, Jet · General & Plastic Surgery
Jun 2023 65d
ERBECRYO 2 Cryosurgical Unit; ERBECRYO 2 1-pedal footswitch, Extension cable f. ERBECRYO 2 footswitch; Flexible Cryoprobe; ERBECRYO 2 Cart, VIO-Cart, Wire basket; Connecting hoses, switching valves, adapter
K190651 · GEH Unit, Cryosurgical,... · General & Plastic Surgery
Jan 2020 300d
APC 3 Argon Plasma Coagulation Unit, VIO 3 Electrosurgical Unit, FiAPC probes, Hybrid APC, APCapplicators, APC Pressure Reducer with Sensor, VIO Cart, Fastening sets
K191234 · GEI Electrosurgical, Cutting... · General & Plastic Surgery
Dec 2019 226d
Erbe ESU Model VIO 3 with Accessories
K190823 · GEI Electrosurgical, Cutting... · General & Plastic Surgery
May 2019 51d
Erbe APCapplicators
K183445 · GEI Electrosurgical, Cutting... · General & Plastic Surgery
Apr 2019 113d
ERBE ESU Model VIO dV with Accessories
K150364 · GEI Electrosurgical, Cutting... · General & Plastic Surgery
May 2016 448d
ERBOKRYO CA CRYOSURGICAL SYSTEM
K934261 · GEH Unit, Cryosurgical,... · General & Plastic Surgery
Apr 1994 238d
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