Joimax Electrosurgical Instruments
FDA 510(k)Class II (US FDA 510(k))
by Joimax GmbH
Identifiers
- 510(k) Number
- K161378 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)
Joimax Electrosurgical Instruments are radio frequency electrosurgical units designed for use in general and plastic surgery procedures. The device is substantially equivalent to predicate devices cleared under the FDA 510(k) pathway.
These instruments are supplied by Joimax GmbH and are intended for use in endoscopic, minimally invasive spinal surgery applications including decompression, stabilization, and joint-specific procedures. The device is non-sterile, reusable, and not indicated for MRI environments. Storage and handling should follow manufacturer guidelines as outlined in the user manual.
Frequently asked questions
What are joimax Electrosurgical Instruments used for?
Joimax Electrosurgical Instruments are radio frequency electrosurgical units designed for use in general and plastic surgery procedures, including endoscopic, minimally invasive spinal surgery applications such as decompression, stabilization, and joint-specific procedures.
Are joimax Electrosurgical Instruments sterile or non-sterile, and are they single-use or reusable?
The devices are supplied non-sterile and are intended for reuse; they are not indicated for single-use applications and must be cleaned and sterilized according to the manufacturer's guidelines before each use.
How are joimax Electrosurgical Instruments supplied and stored?
Joimax Electrosurgical Instruments are supplied by Joimax GmbH in a non-sterile condition and should be stored and handled in accordance with the manufacturer's guidelines as outlined in the user manual to maintain functionality and safety.
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: JOIMAX ENDOVAPOR 2 USER MANUAL Pdf Download | ManualsLib, joimax GmbH Company Overview, Contact Details & Competitors | LeadIQ
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K161378 | Class II | Active |
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Manufacturer
- Manufacturer
- Joimax GmbH
Sources (1)
- FDA 510(k) K161378 24 fields · synced Sep 22, 2026