Sutter CURIS RF Generator— 510(k) K171869
Substantially EquivalentSutter Medizintechnik GmbH
FDA 510(k) clearance K171869 for Sutter CURIS RF Generator, Substantially Equivalent on 2018-02-23. Applicant: Sutter Medizintechnik GmbH. Device class: 2.
Clearance details
- Applicant
- Sutter Medizintechnik GmbH
- Product code
- Code GEI
- 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
- Freiburg, DE
Recent devices under product code GEI
view allMore clearances from Sutter Medizintechnik GmbH
view all- K251813 — CURIS II RF Generator (REF 360100-05)
- K233425 — FlexTip Bipolar electrodes single-use (AR-S9805-0028), FlexTip Bipolar electrodes single-use (AR-S9805-0035)
- K193587 — Sutter Swyng non-stick bipolar forceps, single-use
- K192128 — Sutter Arrowtip Monopolar Electrodes
- K191732 — Sutter RaVoR Bipolar Electrodes
Adverse events under product code GEI
product code GEI- Death
- 133
- Injury
- 7,585
- Malfunction
- 35,808
- Other
- 44
- Total
- 43,570
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.