AlphaTriPart - Monopolar MIC Instruments
by Gimmi GmbH
510(k) K261179
AlphaTriPart - Monopolar MIC Instruments is a Class II device made by Gimmi GmbH, cleared under FDA 510(k) K261179 on 22 Jul 2026, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK261179 | Date22 Jul 2026 | StatusActive |
Official records
- FDA 510(k) database K261179
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- GEI
- Device class
- Class II
- Regulation
- 21 CFR Part 878.4400
- Advisory committee
- General, Plastic Surgery
- FDA decision
- SESE Substantially Equivalent
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