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.
Clearance details
- Applicant
- Gimmi 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
- 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.