# Erbe Elektromedizin GmbH

- Location (FDA's records): Tuebingen, DE
- FDA decisions: 16 (1994–2026): 16 510(k) clearances
- Product codes: GEI (11), GEH (4), FQH (1)
- 510(k) review time since 2016: median 134 days, against 113 for FDA's reviews in the same codes and years (6 of 15 faster)
- Predicates its devices cite: 26 (9 its own); citations of its devices by later devices: 14 (9 its own)
- Recalls linked to its devices: 4 (3 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Erbe USA, Inc.: 14 (https://510kreport.com/company/erbe-usa)
- Starmed Co., Ltd.: 2 (https://510kreport.com/company/starmed)
- Modern Medical Equipment Manufacturing Limited: 1 (https://510kreport.com/company/modern-medical-equipment-manufacturing)

## Firms that cite its devices most
- Serpex Medical, Inc.: 2 (https://510kreport.com/company/serpex-medical)
- Intuitive Surgical, Inc.: 1 (https://510kreport.com/company/intuitive-surgical)
- Erbe USA, Inc.: 1 (https://510kreport.com/company/erbe-usa)
- Endocision Technologies, Inc.: 1 (https://510kreport.com/company/endocision-technologies)

## Its most-cited devices
- K190651: 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 (2020), cited by 6
- K242044: FiAPC plus probes (2024), cited by 1
- K190823: Erbe ESU Model VIO 3 with Accessories (2019), cited by 1
- K231023: ERBEJET® 2 System (2023), cited by 1
- K934261: Erbokryo CA Cryosurgical System (1994), cited by 1
- K240932: HybridTherm System (2024), cited by 1

## Recent decisions
- K261806: ERBECRYO 2 Cryosurgical Unit and Accessories (Jun 9, 2026)
- K253230: ERBECRYO 2 Cryosurgical Unit and Accessories: ERBECRYO 2 cryosurgical unit; Erbe Flexible Cryoprobe (Apr 22, 2026)
- K253915: MOVIVA® Hybrid Ablation Probe (Dec 18, 2025)
- K251108: Erbe ESU Model VIO® 3n with Accessories (Aug 29, 2025)
- K243120: HybridAPC probe (Jun 20, 2025)
- K243451: FiAPC plus probes (Mar 21, 2025)
- K242044: FiAPC plus probes (Aug 26, 2024)
- K240932: HybridTherm System (Aug 5, 2024)

Source page: https://510kreport.com/company/erbe-elektromedizin