# K130110: Meddusa Bipolar System

- Pathway: 510(k) (Traditional)
- Applicant: Elliquence, LLC
- Decided: Oct 8, 2013 after 265 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 K954171 (1996). 9 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003126: Bipolar Trigger-Flex Probe, Ellman Intl., Inc. (2001) Summary page 2.
- K052859: Aquamantys Pump Generator System, Tissuelink Medical, Inc. (2005) Summary page 2.
- K052241: Disc-FX System, Ellman International, Inc. (2006) Summary page 2.

## Most influential descendants
- K190336: Soniquence Bipolar Electrodes (2019), 3 descendants of its own
- K202558: Ellusa Bipolar Wands (2020), 1 descendant of its own
- K222429: Ellusa Reusable Bipolar Cable (2022), 0 descendants of its own
- K211946: Soniquence Reusable Bipolar Cable (2021), 0 descendants of its own

## Indications for use
The Meddusa Bipolar System is a single-use product designed for and intended to be used exclusively with Surgi-MaxtV RF Generators (510(k) K1 00390). For optimal performance the Surgi-Max@ Plus generator (510(k) K100390) is recommended. The Meddusa Tm Bipolar System is intended for use by a physician familiar with bipolar coagulation with electrosurgery where coagulation/contraction of soft tissue is needed. The types of surgery intended are: General surgery, Laparoscopic procedures, Endoscopic procedures, Laryngeal coagulation, Open abdominal, Orthopedic coagulation, Thorascopic coagulation, Neurosurgical coagulation, Gynecological coagulation, (except for use in female sterilization), Ear, Nose, Throat coagulation.

Source page: https://510kreport.com/device/K130110
Methodology: https://510kreport.com/methodology