Omnitech HF Resection Electrodes, Omnitech HF Vaporization Electrode— 510(k) K151976
Substantially EquivalentOmnitech Systems, Inc.
FDA 510(k) clearance K151976 for Omnitech HF Resection Electrodes, Omnitech HF Vaporization Electrode, Substantially Equivalent on 2016-06-27. Applicant: Omnitech Systems, Inc.. Device class: 2.
Clearance details
- Applicant
- Omnitech Systems, Inc.
- Product code
- Code FAS
- Device class
- Class 2
- Regulation
- 21 CFR 876.4300
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Valparaiso, IN, US
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More clearances from Omnitech Systems, Inc.
view allAdverse events under product code FAS
product code FAS- Death
- 3
- Injury
- 344
- Malfunction
- 1,130
- Total
- 1,477
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.