# K161378: joimax Electrosurgical Instruments

- Pathway: 510(k) (Traditional)
- Applicant: Joimax GmbH
- Decided: Nov 2, 2016 after 168 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: 2 generations back to K931338 (1994). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K014201: Aaron Reusable Electrosurgical Electrode, Aaron Medical Industries (2002) Summary page 5.
- K003126: Bipolar Trigger-Flex Probe, Ellman Intl., Inc. (2001) Summary page 5.

## Most influential descendants
- K211173: maxmorespine Bipolar Electrodes (2022), 0 descendants of its own

## Indications for use
joimax® Bipolar Electrosurgical Instruments The joimax® bipolar Vaporflex and Legato electrosurgical instruments are used for coagulation of soft tissue during open or minimally invasive surgical procedures when used in conjunction with a compatible radio frequency generator. The joimax® bipolar electrosurgical instruments have not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures and should not be used for these procedures. joimax® Monopolar Electrosurgical Instruments The joimax® monopolar Legato electrosurgical instruments are used for cutting and/or coagulating soft tissue during open or minimally invasive surgical procedures when used in conjunction with a compatible radio frequency generator. The joimax® monopolar electrosurgical instruments have not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures and should not be used for these procedures.

Source page: https://510kreport.com/device/K161378
Methodology: https://510kreport.com/methodology