Rita StarBurst SDE Electrosurgical Device

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K030967 ↗

FDA Product Code

GEI

Device Class

Class II

Regulation

21 CFR Part 878.4400

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

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• Rita Rf Generator and Accessories, Model 500 Series

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• Rita System

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See all devices from Rita Medical Systems, Inc. →

• What is the Rita StarBurst SDE Electrosurgical Device used for?

  The Rita StarBurst SDE Electrosurgical Device is designed for controlled delivery of electrosurgical energy to facilitate precise tissue coagulation and ablation. It is particularly suited for percutaneous, laparoscopic, or intraoperative procedures, enabling targeted treatment of non-resectable soft tissue lesions—either partially or completely—under direct visualization or imaging guidance.

• How is the Rita StarBurst SDE Electrosurgical Device supplied and used?

  This device is supplied as a reusable medical instrument and requires pairing with an external electrosurgical generator for operation. It is not a standalone unit but relies on the generator’s energy output to perform coagulation and ablation tasks in surgical settings.

• Is sterility or MRI safety information provided for the Rita StarBurst SDE?

  The available regulatory data does not specify sterility requirements or MRI safety details for the Rita StarBurst SDE Electrosurgical Device. Users should follow standard surgical protocols for cleaning, sterilization, and handling reusable devices, and consult manufacturer guidelines for MRI compatibility.

• What regulatory pathway does the Rita StarBurst SDE follow?

  The device underwent a Special 510(k) review process under the FDA’s Substantially Equivalent (SESE) determination, classified under Product Code GEI (General, Plastic Surgery). It received clearance with the 510(k) number K030967 in 2003, affirming its equivalence to a predicate device.

• Can the Rita StarBurst SDE be used in minimally invasive procedures?

  Yes, the device is explicitly designed for percutaneous and laparoscopic applications, in addition to traditional intraoperative use. Its electrosurgical capabilities allow for controlled energy delivery in minimally invasive settings where direct visualization or imaging guidance is available.