AlphaTriPart - Monopolar MIC Instruments— 510(k) K261179
Substantially EquivalentGimmi GmbH
FDA 510(k) clearance K261179 for AlphaTriPart - Monopolar MIC Instruments, Substantially Equivalent on 2026-07-22. Applicant: Gimmi GmbH. Device class: 2.
Summary
Gimmi's AlphaTriPart monopolar MIC instruments are filed under GEI, electrosurgical cutting and coagulation devices and accessories. The record doesn't expand "MIC" or list the instruments.
Class II, 21 CFR 878.4400. General and Plastic Surgery is both the classification panel and the review panel, and it was a Traditional 510(k).
Gimmi filed from Tuttlingen, Germany. Review took 103 calendar days (April 10 to July 22, 2026).
Clearance details
- Applicant
- Gimmi 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
- Tuttlingen, DE
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More clearances from Gimmi GmbH
view all- K092421 — ALPHAHYSTEROSCOPE, FIBEROPTIC, OPERATIVE AND DIAGNOSTIC
- K093125 — ALPHAXENON LIGHT 180 W AND 300 W
- K081640 — GIMMI ANEURYSM CLIPS AND APPLYING FORCEPS
- K012869 — GIMMI ALPHA HYSTEROSCOPES & ACCESSORIES, MODELS E.8XXX.XX, T.8XXX.XX, ZXXX.XX,S.XXXX.XX, K0142.25
- K012660 — GIMMI'ALPHA' ENDOSCOPES & ACCESSORIES
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.