CURIS II RF Generator (REF 360100-05)— 510(k) K251813
Substantially EquivalentSutter Medizintechnik GmbH
FDA 510(k) clearance K251813 for CURIS II RF Generator (REF 360100-05), Substantially Equivalent on 2026-02-11. Applicant: Sutter Medizintechnik GmbH. Device class: 2.
Summary
Sutter Medizintechnik's CURIS II RF Generator (REF 360100-05) is filed under product code GEI (Electrosurgical, Cutting & Coagulation & Accessories). The record doesn't describe the generator beyond its name and that code name.
Class II, 21 CFR 878.4400. General, Plastic Surgery is both the classification panel and the review panel, and it came in as a Traditional 510(k).
Sutter Medizintechnik filed from Emmendingen, Germany. The decision came 243 calendar days after FDA received it (June 13, 2025 to February 11, 2026), and it was substantially equivalent.
Clearance details
- Applicant
- Sutter Medizintechnik GmbH
- Product code
- Product 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
- Emmendingen, DE
Recent devices under product code GEI
view all- K262720 — SP Electrocautery Device (SP18 Max); SP Electrocautery Device (SP20 Max)
- K262386 — SafeAir Electrosurgical Generator with Smoke Evacuation (0795-001-000) +1 more
- K254196 — HARMONIC 1100 Shears (HAR1120); HARMONIC 1100 Shears (HAR1136)
- K261959 — Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, Push Button Switch (0703-046-100) +3 more
- K261070 — LigaSure RAS Maryland Jaw Vessel Sealer/Divider, Nano-coated
More clearances from Sutter Medizintechnik GmbH
view all- 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
- K171869 — Sutter CURIS RF Generator
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.