SEEDNET, SEEDNET GOLD, CRYOHIT, CRYO THERA— 510(k) K060390
Substantially EquivalentGalil Medical , Ltd.
FDA 510(k) clearance K060390 for SEEDNET, SEEDNET GOLD, CRYOHIT, CRYO THERA, Substantially Equivalent on 2006-04-27. Applicant: Galil Medical , Ltd.. Device class: 2.
Clearance details
- Applicant
- Galil Medical , Ltd.
- Product code
- Code GEH
- Device class
- Class 2
- Regulation
- 21 CFR 878.4350
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Washington, DC, US
Recent devices under product code GEH
view all- K262420 — Maverix Cryo Biopsy Pro (MCB Pro) (MCBP-1000); Maverix Cryo Cartridge (CC-1000)
- K261068 — Maverix Cryo Biopsy Probe (MCB1000); Maverix Cryo Cartridge (CC1000)
- K261806 — ERBECRYO 2 Cryosurgical Unit and Accessories
- K253230 — ERBECRYO 2 Cryosurgical Unit and Accessories: ERBECRYO 2 cryosurgical unit; Erbe Flexible Cryoprobe
- K252198 — Advanced Cryo Skin Tag Remover (Advanced Skin Tag Remover)
More clearances from Galil Medical , Ltd.
view all- K181741 — IceSphere 1.5 CX Cryoablation Needle
- K162599 — IcePearl 2.1 CX L, IceForce 2.1 CX L
- K152133 — IcePearl 2.1 CX Cryoablation Needle, IcePearl 2.1 CX Prostate Cryoablation Kit Visual-ICE System, IceFORCE 2.1 CX Cryoablation Needle, IceFORCE 2.1 CX Prostate Cryoablation Kit Visual-ICE System
- K141485 — ICESPHERE 1.5 90 CRYOBLATION NEEDLE, ICESHPERE 1.5 CYOBLATION NEEDLE
- K140584 — ICEROD CX CRYOABLATION NEEDLE
Adverse events under product code GEH
product code GEH- Death
- 25
- Injury
- 351
- Malfunction
- 901
- Total
- 1,277
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K060390
K-number listed on FDA's recall record- Z-0665-2021 — IceRod" 1.5 i-Thaw" Cryoablation Needle
- Z-0673-2021 — IceSphere" 1.5 90¿ Cryoablation Needle
- Z-0674-2021 — IceSphere" 1.5 Cryoablation Needle
- Z-0686-2021 — IceRod" i-Thaw" Prostate Cryoablation Kit
- Z-0691-2021 — IceRod" i-Thaw" Prostate Cryoablation Kit
- Z-0692-2021 — IceSeed" Prostate Cryoablation Kit
- Z-0693-2021 — IceRod" He-Thaw Prostate Cryoablation Kit
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K060390.
Data sourced from openFDA. This site is unofficial and independent of the FDA.