CERTUS 140 MICROWAVE ABLATION SYSTEM AND ACCESSORIES, MODEL CERTUS 140— 510(k) K100744
Substantially EquivalentNeuwave Medical, Inc.
FDA 510(k) clearance K100744 for CERTUS 140 MICROWAVE ABLATION SYSTEM AND ACCESSORIES, MODEL CERTUS 140, Substantially Equivalent on 2010-10-22. 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.