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Meddusa Bipolar System

FDA 510(k)

Class II (US FDA 510(k))

510(k) K130110

by Elliquence, Llc

Identifiers

510(k) Number
K130110 FDA 510(k)
FDA Product Code
GEI FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 878.4400 FDA 510(k)
Regulation Number
878.4400 FDA 510(k)
Advisory Committee
General, Plastic Surgery FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Meddusa Bipolar System is an electrosurgical device classified as an accessory for cutting and coagulation procedures. It is designed to work with radiofrequency generators to deliver controlled bipolar energy for tissue treatment, primarily in surgical settings. The system is intended for transient patient contact, typically lasting less than one hour, and is categorized under general and plastic surgery applications. Its function relies on precise energy delivery to achieve hemostasis or tissue modification during procedures.

This device is supplied as a single-use, sterile product and is intended for exclusive use with the elliquence Surgi-Max or Surgi-Max Plus Radiofrequency Generator (510(k) K100390). It falls under FDA regulation 878.4400 and was granted a 510(k) clearance under the Traditional review pathway, classified as substantially equivalent (SESE). No additional sterility, MRI safety, or reusable specifications are noted in the regulatory data.

Frequently asked questions

What is the Meddusa Bipolar System used for in surgical procedures?

The Meddusa Bipolar System is an electrosurgical accessory designed to work with radiofrequency generators like the elliquence Surgi-Max or Surgi-Max Plus. It provides controlled bipolar energy for hemostasis (stopping bleeding) or tissue modification during general and plastic surgery procedures. The system ensures precise energy delivery to achieve these effects safely and effectively.

How is the Meddusa Bipolar System supplied, and what are its sterility and reuse specifications?

The Meddusa Bipolar System is supplied as a single-use, sterile product. It is not intended for reuse, and no additional sterility or reusable specifications are noted beyond its sterile packaging for one-time patient contact. This ensures compliance with surgical best practices for infection control and patient safety.

Which radiofrequency generators is this system compatible with, and is there any regulatory approval noted?

The Meddusa Bipolar System is exclusively compatible with the elliquence Surgi-Max or Surgi-Max Plus Radiofrequency Generator (510(k) K100390). It has received FDA clearance under the Traditional review pathway, classified as substantially equivalent (SESE) for use in general and plastic surgery applications, as outlined in the regulatory filing.

What are the key specifications or limitations for patient contact with this device?

The Meddusa Bipolar System is intended for transient patient contact, meaning it is designed for use during surgical procedures lasting less than one hour. This limitation ensures safe and controlled energy delivery without prolonged exposure, aligning with its intended surgical applications.

Is there any information about storage or handling requirements for this device?

While the provided data does not specify detailed storage or handling instructions, the Meddusa Bipolar System is supplied sterile and single-use. Standard sterile medical device storage practices—such as protecting from contamination, extreme temperatures, and physical damage—should be followed to maintain its integrity until use.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: PDF 510 (k) Summary - Food and Drug Administration, MEDDUSA BIPOLAR SYSTEM (K130110) — FDA 510 (k) | Innolitics, MEDDUSA BIPOLAR SYSTEM 510 (k) K130110 - FDA.report

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Elliquence, Llc

Sources (1)

  • FDA 510(k) K130110 24 fields · synced Oct 1, 2026