Endopath Electrosurgery Probe Plus II
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K180031 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 Endopath Electrosurgery Probe Plus II is a monopolar electrosurgical probe designed for tissue dissection, coagulation, and cutting during surgical procedures. Classified under the General, Plastic Surgery advisory committee category, it delivers controlled electrical energy to achieve precise tissue effects in minimally invasive and open surgeries.
Supplied as a single-use, sterile device, the Endopath Electrosurgery Probe Plus II is intended for use in operating rooms and surgical settings. It is regulated under FDA 510K clearance, MDD, and MDR, with the product code GEI. Proper storage requires adherence to manufacturer guidelines to maintain sterility and functionality.
Frequently asked questions
What types of surgical procedures is the Endopath Electrosurgery Probe Plus II designed for?
The Endopath Electrosurgery Probe Plus II is designed for both minimally invasive and open surgeries, where precise tissue dissection, coagulation, and cutting are required. Its monopolar electrosurgical function makes it suitable for general surgical applications, including those in plastic surgery, as classified under the General, Plastic Surgery advisory committee category.
Is the Endopath Electrosurgery Probe Plus II intended for reuse, or is it single-use only?
The Endopath Electrosurgery Probe Plus II is explicitly supplied as a single-use, sterile device, meaning it is intended for one-time use only in surgical settings. Reuse is not recommended or supported by the manufacturer to ensure safety and sterility.
How should I store the Endopath Electrosurgery Probe Plus II to maintain its sterility and functionality?
The device must be stored according to the manufacturer’s guidelines to preserve sterility and functionality. Since it is single-use and sterile upon packaging, it should remain in its original, unopened packaging until use. Avoid exposure to moisture, extreme temperatures, or physical damage, as these could compromise its performance or sterility.
What regulatory pathways has the Endopath Electrosurgery Probe Plus II undergone?
The Endopath Electrosurgery Probe Plus II has received FDA 510(k) clearance, as well as compliance under the Medical Device Directive (MDD) and Medical Device Regulation (MDR). Its product code is GEI, and it was classified under the General, Plastic Surgery advisory committee category, indicating its intended use in those surgical contexts.
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.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K180031 | Class II | Active |
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Manufacturer
- Manufacturer
- Ethicon Endo-Surgery, LLC
Sources (2)
- FDA 510(k) K180031 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 29, 2026