# K261179: AlphaTriPart - Monopolar MIC Instruments

- Pathway: 510(k) (Traditional)
- Applicant: Gimmi GmbH
- Decided: Jul 22, 2026 after 103 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K945975 (1994). 18 ancestors in all.
No later device cites it as a predicate yet.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K954122: Take-Apart Scissors, KARL STORZ Endoscopy-America, Inc. (1995) Summary page 5.
- K935071: Insulated Forceps, Biopsy Forceps, Scissors, KARL STORZ Endoscopy-America, Inc. (1994) Summary page 5.
- K060232: Trokamed GMBH Electrosurgical Instruments & Accessories, Trokamed GmbH (2006)

## Indications for use
Instruments for laparoscopic surgery are intended for cutting, resecting, gripping and coagulating of body tissue.

Source page: https://510kreport.com/device/K261179
Methodology: https://510kreport.com/methodology