AlphaTriPart - Monopolar MIC Instruments
FDA 510(k) K261179 · Gimmi GmbH
510(k) numberK261179
Submission
- Device name
- AlphaTriPart - Monopolar MIC Instruments
- Applicant
- Gimmi GmbH
Tuttlingen, DE - Received
- April 10, 2026
- Decision date
- July 22, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GEI – Electrosurgical, Cutting & Coagulation & Accessories
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4400
- Specialty
- General, Plastic Surgery
Validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission if the device is reusable and has specific design features (please refer to Table 2 of 82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
Other 510(k)s with product code GEI
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K254185 | Potenza PrimeGEI · Traditional | Jeisys Medical Incorporated | 09/11/2026SE |
| K262364 | Ellian Enigma RF DeviceGEI · Traditional | Ellian Corp | 09/02/2026SE |
| K253859 | Scarlet Pro (Scarlet Pro)GEI · Traditional | VIOL Co., Ltd. | 08/27/2026SE |
| K252535 | Inno-Switch Laparoscopic InstrumentsGEI · Traditional | Taiwan Surgical Corporation | 08/25/2026SE |
| K253504 | VolnewmerGEI · Traditional | Classys, Inc. | 07/13/2026SE |
| K254056 | THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type S (TB-0545FCS); THUNDERBEAT 5 mm, 35…GEI · Traditional | Olympus Medical Systems Corp. | 07/01/2026SE |
| K253484 | Lutronic GeniusGEI · Traditional | Cynosure Lutronic Technology Corporation | 06/29/2026SE |
| K251492 | Irrigation Tubing Bipolar Cord SetGEI · Traditional | New Deantronics Taiwan , Ltd. | 06/29/2026SE |
| K260636 | Remanufactured LigaSure XP Maryland Jaw Sealer/Divider Without Nano-coatingGEI · Traditional | Stryker Sustainability Solutions | 06/18/2026SE |
| K253634 | CoolSeal Generator® (CSL-200-90)GEI · Traditional | Hologic, Inc. | 06/17/2026SE |
More from Hologic, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K092421 | Alphahysteroscope, Fiberoptic, Operative and DiagnosticHIH · Abbreviated | 02/12/2010SE |
| K093125 | Alphaxenon Light 180 W and 300 WGCT · Abbreviated | 01/27/2010SE |
| K081640 | Gimmi Aneurysm Clips and Applying ForcepsHCH · Abbreviated | 05/06/2009SE |
| K012869 | Gimmi Alpha Hysteroscopes & Accessories, Models E.8XXX.XX, T.8XXX.XX, Zxxx.Xx,S.Xxxx.Xx…HIH · Abbreviated | 03/11/2002SE |
| K012660 | Gimmi'Alpha' Endoscopes & AccessoriesFET · Abbreviated | 12/20/2001SE |
| K013731 | Gimmi Alpha Sinuscopes Model # E.8282.01/31/71 + E.8284.01/31/71; Gimmi Alpha…EOQ · Traditional | 11/27/2001SE |
Questions and answers
When was AlphaTriPart - Monopolar MIC Instruments cleared by the FDA?
AlphaTriPart - Monopolar MIC Instruments (K261179) received a 510(k) decision of Substantially Equivalent on July 22, 2026, 103 days after the submission was received.
What is the product code of K261179?
The FDA product code is GEI – Electrosurgical, Cutting & Coagulation & Accessories, a Class II (moderate risk) device regulated under 21 CFR 878.4400.