K261179
- 510(k) number
- K261179
- Device name
- AlphaTriPart - Monopolar MIC Instruments
- Applicant
- Gimmi GmbH DE
- Product code
- GEI — Electrosurgical, Cutting & Coagulation & Accessories
- Decision date
- 2026-07-22
- Date received
- 2026-04-10
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 1.4 MB · U.S. public domain
Also available from FDA: K261179.pdf
Official FDA record: K261179
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.