CryoDose H or Similar— 510(k) K161337
Substantially EquivalentNuance Medical, LLC
FDA 510(k) clearance K161337 for CryoDose H or Similar, Substantially Equivalent on 2016-07-12. Applicant: Nuance Medical, LLC. Device class: 2.
Clearance details
- Applicant
- Nuance Medical, LLC
- 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
- Carlsbad, CA, 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 Nuance Medical, LLC
view all- K232674 — PainFreeze II
- K210310 — CryoDose V 50/50, 175ml Canister Kit, CryoDose V 50/50, 236ml Canister Kit
- K172203 — CryoDose TA OTC, Mist Spray, CryoDose TA OTC, Stream Spray
- K162218 — Pain Freeze, Medium Stream Spray, Model #2101; Pain Freeze, Mist Spray, Model #2102
- K130995 — NUANCE CRYO-FREEZE SPRAY OR CRYO-IN-A-CAN OR VANDOLAY FREEZE SPRAY
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.