ATRICURE CRYO MODULE SYSTEM— 510(k) K140058
Substantially EquivalentAtriCure, Inc.
FDA 510(k) clearance K140058 for ATRICURE CRYO MODULE SYSTEM, Substantially Equivalent on 2014-01-24. Applicant: AtriCure, Inc.. Device class: 2.
Clearance details
- Applicant
- AtriCure, Inc.
- 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
- West Chester, OH, 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 AtriCure, Inc.
view allAdverse 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 K140058
K-number listed on FDA's recall record- Z-0927-2024 — Cryo Module Accessories Domestic CMA-OUS, Product Catalog Number A001053
- Z-0928-2024 — Packaged, Tank Hose Assembly CMA-US, Product Catalog Number A001056
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K140058.
Data sourced from openFDA. This site is unofficial and independent of the FDA.