IR-192 Implant

FDA 510(k) K874895 · Rads S.L., Inc.

Substantially Equivalent

510(k) numberK874895

Submission

Device name
IR-192 Implant
Applicant
Rads S.L., Inc.
Lake Charles, LA, US
Received
December 1, 1987
Decision date
February 25, 1988
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
IWA – Source, Wire, Iridium, Radioactive
Device class
Class II (moderate risk)
Regulation
21 CFR 892.5730
Specialty
Radiology

Other 510(k)s with product code IWA

510(k)DeviceApplicantDecision
K915253IR-192 Implant, ModificationIWA · Traditional Omnitron Intl., Inc.02/27/1992SE
K894409CESIUM-137 Microseed Source Train Assembly/ShieldIWA · Traditional Amersham Corp.09/29/1989SE
K850382Iridium SeedsIWA · Traditional Radiation Safety & Nuclear Products, Inc.08/15/1985SE
K844248IR-192 ImplantIWA · Traditional Rads S.L., Inc.04/10/1985SE
K850726Wire Cutters, Brachytherapy-Table Top & Hand HeldIWA · Traditional Syncor Intl. Corp.03/26/1985SE
K850163Iridium 192 WiresIWA · Traditional Syncor Intl. Corp.03/26/1985SE
K771878Iridium 192 Wires & PinsIWA · Traditional Cis Radiopharmaceuticals, Inc.10/27/1977SE

More from Cis Radiopharmaceuticals, Inc.

510(k)DeviceDecision
K903465IR-192 ImplantKXK · Traditional 10/12/1990SE
K844248IR-192 ImplantIWA · Traditional 04/10/1985SE

Questions and answers

When was IR-192 Implant cleared by the FDA?

IR-192 Implant (K874895) received a 510(k) decision of Substantially Equivalent on February 25, 1988, 86 days after the submission was received.

What is the product code of K874895?

The FDA product code is IWA – Source, Wire, Iridium, Radioactive, a Class II (moderate risk) device regulated under 21 CFR 892.5730.