Plasma Edge resection and vaporization electrodes, Plasma Edge working elements, Adaptor Plasma Edge— 510(k) K213135
Substantially EquivalentChirurgie Innovation
FDA 510(k) clearance K213135 for Plasma Edge resection and vaporization electrodes, Plasma Edge working elements, Adaptor Plasma Edge, Substantially Equivalent on 2022-03-02. Applicant: Chirurgie Innovation. Device class: 2.
Clearance details
- Applicant
- Chirurgie Innovation
- 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
- Special
- Location
- Verrières Le Buisson, FR
Recent devices under product code FAS
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More clearances from Chirurgie Innovation
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.