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UniBlate Electrosurgical Device

FDA 510(k)

Class II (US FDA 510(k))

510(k) K080451

by Angiodynamics, Inc.

Identifiers

510(k) Number
K080451 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 UniBlate Electrosurgical Device is a radiofrequency ablation electrode (Product Code: GEI) designed for coagulation and ablation of tissue. It is classified under the electrosurgical device category and is intended for percutaneous, laparoscopic, and intraoperative procedures. The device delivers controlled energy to achieve localized tissue ablation, including non-resectable lesions, osteoid osteoma, and metastatic bone lesions. Its design enables targeted treatment while minimizing damage to surrounding healthy tissue.

The UniBlate Electrosurgical Device is supplied as a reusable medical instrument and is intended for use in sterile surgical settings. It is regulated under FDA 510(k) clearance (K080451) and was reviewed by the Surgical Devices Panel (SU) under the General, Plastic Surgery advisory committee. No specific MRI safety classification is stated, and its use requires adherence to standard electrosurgical safety protocols. The device is distributed by AngioDynamics, Inc., with specifications and regulatory details documented in the FDA submission.

Frequently asked questions

What is the UniBlate Electrosurgical Device used for?

The UniBlate Electrosurgical Device is designed for coagulation and ablation of tissue, specifically targeting non-resectable lesions, osteoid osteoma, and metastatic bone lesions. Its radiofrequency energy allows controlled treatment while minimizing damage to surrounding healthy tissue, making it suitable for percutaneous, laparoscopic, and intraoperative procedures.

Is the UniBlate Electrosurgical Device single-use or reusable?

The UniBlate Electrosurgical Device is supplied as a reusable medical instrument. It is intended for use in sterile surgical settings, requiring proper cleaning and maintenance between procedures to ensure safety and efficacy.

What types of procedures can the UniBlate Electrosurgical Device be used in?

This device is intended for percutaneous (through the skin), laparoscopic (minimally invasive with a camera), and intraoperative (during surgery) procedures. Its design allows for targeted tissue ablation in various surgical contexts while maintaining precision and safety.

Does the UniBlate Electrosurgical Device have any specific MRI safety classification?

The UniBlate Electrosurgical Device does not have a stated MRI safety classification in its documentation. As with all electrosurgical devices, its use requires adherence to standard safety protocols, and MRI compatibility should be confirmed based on the specific surgical environment and equipment in use.

Who is the manufacturer and regulatory applicant for the UniBlate Electrosurgical Device?

The UniBlate Electrosurgical Device is manufactured and distributed by AngioDynamics, Inc. The device received FDA 510(k) clearance (K080451) and was reviewed by the Surgical Devices Panel (SU) under the General, Plastic Surgery advisory committee.

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: UNIBLATE ELECTROSURGICAL DEVICE (K080451) — FDA 510 (k) | Innolitics, UNIBLATE ELECTROSURGICAL DEVICE (K080451) - FDA 510 (k), Electrosurgical electrode - UniBlate™ - Angiodynamics - ablation ..., RITA UniBlate Electrosurgical Device User Manual | Manualzz

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Angiodynamics, Inc.

Sources (1)

  • FDA 510(k) K080451 24 fields · synced Oct 1, 2026