Radionics Disposable RF Cannulae (Sc-C, Rfk-Db, Rfk-Ds)
FDA 510(k) K980430 · Radionics, Inc.
510(k) numberK980430
Submission
- Device name
- Radionics Disposable RF Cannulae (Sc-C, Rfk-Db, Rfk-Ds)
- Applicant
- Radionics, Inc.
Burlington, MA, US - Received
- February 4, 1998
- Decision date
- March 16, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Radionics Disposable RF Cannulae (Sc-C, Rfk-Db, Rfk-Ds) cleared by the FDA?
Radionics Disposable RF Cannulae (Sc-C, Rfk-Db, Rfk-Ds) (K980430) received a 510(k) decision of Substantially Equivalent on March 16, 1998, 40 days after the submission was received.
What is the product code of K980430?
The FDA product code is GXI – Probe, Radiofrequency Lesion, a Class II (moderate risk) device regulated under 21 CFR 882.4725.