Identifiers
- 510(k) Number
- K941251 FDA 510(k)
- FDA Product Code
- HGI FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 884.4120 FDA 510(k)
- Regulation Number
- 884.4120 FDA 510(k)
- Advisory Committee
- Obstetrics/Gynecology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Finesse IEC/601 is an electrocautery device designed for gynecologic procedures, including loop electrosurgical excision procedures (LEEP). It delivers controlled electrical energy to coagulate, cut, or ablate tissue, reducing bleeding and improving precision during surgical interventions. This device is classified as a Class II medical device under FDA regulations, intended for use in obstetrics and gynecology settings.
The Finesse IEC/601 is supplied as a reusable electrosurgical generator, requiring proper calibration and maintenance per manufacturer guidelines. It is not sterile upon delivery and must be sterilized before use in clinical settings. The device is MRI-unsafe and must be used in non-MRI environments. Authorized under FDA 510(k) clearance (K941251), it adheres to IEC/601 safety standards and is intended for office-based or procedural room use in gynecological surgeries. Storage and handling follow standard electrosurgical equipment protocols.
Frequently asked questions
What is the Finesse IEC/601 used for in gynecologic procedures?
The Finesse IEC/601 is an electrocautery device designed specifically for gynecologic surgeries, including loop electrosurgical excision procedures (LEEP). It provides controlled electrical energy to coagulate, cut, or ablate tissue, which helps minimize bleeding and enhances precision during procedures like cervical lesion removal or other obstetrics/gynecology interventions.
Is the Finesse IEC/601 reusable or single-use?
The Finesse IEC/601 is a reusable electrosurgical generator. It is not intended for single-use and must be properly calibrated, maintained, and sterilized before each clinical application to ensure safety and performance.
How should the Finesse IEC/601 be sterilized before use?
The device is not sterile upon delivery and must undergo sterilization using validated methods suitable for electrosurgical equipment. Follow the manufacturer’s guidelines for sterilization protocols, including appropriate cleaning, packaging, and sterilization techniques (e.g., steam autoclave, ethylene oxide, or other approved methods) to ensure sterility before clinical use.
Can the Finesse IEC/601 be used in an MRI environment?
No, the Finesse IEC/601 is MRI-unsafe and must only be used in non-MRI environments. Electrocautery devices like this one can interfere with MRI systems, posing risks to patients and equipment, so strict adherence to non-MRI protocols is required.
What regulatory approval does the Finesse IEC/601 hold?
The Finesse IEC/601 is authorized under FDA 510(k) clearance (K941251) and adheres to IEC/601 safety standards. It is classified as a Class II medical device under FDA regulations, intended exclusively for use in obstetrics and gynecology settings. The clearance confirms it is substantially equivalent to a legally marketed predicate device.
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: FINESSE IEC/601 (K941251) — FDA 510 (k) | Innolitics, LEEP Surgery Electrosurgical Generator - Finesse - Utah Med, Electrosurgery Products - Utah Medical, PDF 8.0 510(k) Summary - Food and Drug Administration
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K941251 | Class II | Active |
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Manufacturer
- Manufacturer
- Utah Medical Products, Inc.
Sources (1)
- FDA 510(k) K941251 24 fields · synced Oct 6, 2026