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joimax Endovapor 2

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K170358

by Joimax GmbH

Identifiers

510(k) Number
K170358 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 joimax Endovapor 2 (JEVD0202) is a Multi Radio Frequency System classified under product code GEI (General, Plastic Surgery) for endoscopic spine surgery. It employs mono- and bipolar RF probes to perform tissue vaporization, coagulation, and electrosurgical procedures, facilitating minimally invasive interventions in spinal applications.

This sterile, single-use device is designed for endoscopic surgery settings, including MRI-compatible environments where applicable. Supplied as a complete RF generator system, it requires no additional preparation beyond standard surgical instrumentation. Authorised under FDA 510(k) clearance and MDR compliance, the Endovapor 2 adheres to regulatory standards for electrosurgical devices in spinal and soft-tissue procedures.

Frequently asked questions

What types of surgical procedures is the joimax Endovapor 2 designed to assist with in spinal applications?

The joimax Endovapor 2 is specifically designed for endoscopic spine surgery, utilizing mono- and bipolar RF probes to perform tissue vaporization, coagulation, and electrosurgical procedures. This enables minimally invasive interventions in spinal applications, including procedures where precision tissue modification is required.

Is the joimax Endovapor 2 compatible with MRI environments, and how does this affect its use?

Yes, the joimax Endovapor 2 is designed for use in MRI-compatible environments where applicable. This feature allows it to be utilized in settings where MRI imaging is required during or after the procedure, ensuring seamless integration with diagnostic workflows.

How is the joimax Endovapor 2 supplied, and what preparations are needed before use?

The joimax Endovapor 2 is supplied as a complete RF generator system, meaning no additional preparation beyond standard surgical instrumentation is required. It is also sterile and single-use, ensuring readiness for immediate use in endoscopic surgery settings without extra setup.

What regulatory pathways has the joimax Endovapor 2 followed, and what does this mean for its use?

The joimax Endovapor 2 has been authorized under both FDA 510(k) clearance and MDR compliance, adhering to regulatory standards for electrosurgical devices. This means it meets the necessary safety and performance requirements for use in spinal and soft-tissue procedures in markets where these approvals apply.

Is the joimax Endovapor 2 reusable, or is it intended for single-use only?

The joimax Endovapor 2 is explicitly designed as a single-use device. This ensures sterility and reduces the risk of cross-contamination, aligning with best practices for endoscopic surgical instruments in clinical settings.

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: Endovapor® 2 - Multi Radio Frequency System - joimax®, Endovapor®2 - joimax®, JOIMAX ENDOVAPOR 2 USER MANUAL Pdf Download | ManualsLib, Joimax Endovapor 2 Multi Radio Frequency System, Joimax Endovapor 2 Manuals | ManualsLib

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
Joimax GmbH

Sources (2)

  • FDA 510(k) K170358 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced Jun 19, 2026