SEEDNET, SEEDNET GOLD, CRYOHIT, CRYOTHERA— 510(k) K052530
Substantially EquivalentGalil Medical , Ltd.
FDA 510(k) clearance K052530 for SEEDNET, SEEDNET GOLD, CRYOHIT, CRYOTHERA, Substantially Equivalent on 2005-11-18. 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
- Traditional
- Location
- Washington, DC, US
Recent devices under product code GEH
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- 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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.