510(k) K190651 ยท GEH Unit, Cryosurgical, Accessories
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
| Applicant | Erbe Elektromedizin GmbH, Tuebingen, DE |
| Decision | Substantially Equivalent, Jan 7, 2020 |
| Received | Mar 13, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K190651
| 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 | None listed |
| 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 | None listed |
| Mar 20, 2026 | Erbe USA Inc Flexible Cryoprobe (OD 1.7mm, L1.15mm)
REF: 20402-410. For surgical use Open, Classified |
GEH | None listed |
| Mar 20, 2026 | Erbe USA Inc Flexible Cryoprobe (OD 2.4mm, L1.15mm)
REF: 20402-411. For surgical use Open, Classified |
GEH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.