Radionuclide Catheters, Rnc-A, Rnc-G, Rnc-U

FDA 510(k) K923697 · Radionics, Inc.

Substantially Equivalent

510(k) numberK923697

Submission

Device name
Radionuclide Catheters, Rnc-A, Rnc-G, Rnc-U
Applicant
Radionics, Inc.
Burlington, MA, US
Received
July 24, 1992
Decision date
December 13, 1993
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
KXK – Source, Brachytherapy, Radionuclide
Device class
Class II (moderate risk)
Regulation
21 CFR 892.5730
Specialty
Radiology
Implant
Yes

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Questions and answers

When was Radionuclide Catheters, Rnc-A, Rnc-G, Rnc-U cleared by the FDA?

Radionuclide Catheters, Rnc-A, Rnc-G, Rnc-U (K923697) received a 510(k) decision of Substantially Equivalent on December 13, 1993, 507 days after the submission was received.

What is the product code of K923697?

The FDA product code is KXK – Source, Brachytherapy, Radionuclide, a Class II (moderate risk) device regulated under 21 CFR 892.5730.