CERTUS 140 2.45GHZ ABLATION SYSTEM— 510(k) K122217
Substantially EquivalentNeuwave Medical, Inc.
FDA 510(k) clearance K122217 for CERTUS 140 2.45GHZ ABLATION SYSTEM, Substantially Equivalent on 2012-12-19. Applicant: Neuwave Medical, Inc.. Device class: 2.
Clearance details
- Applicant
- Neuwave Medical, Inc.
- Product code
- Code NEY
- Device class
- Class 2
- Regulation
- 21 CFR 878.4400
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Madision, WI, US
Recent devices under product code NEY
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- K241825 — Microwave Ablation Antennas
More clearances from Neuwave Medical, Inc.
view allAdverse events under product code NEY
product code NEY- Death
- 24
- Injury
- 388
- Malfunction
- 462
- Other
- 1
- Total
- 875
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.