Gliasite RTS

FDA 510(k) K111931 · Isoray Medical, Inc.

Substantially Equivalent

510(k) numberK111931

Submission

Device name
Gliasite RTS
Applicant
Isoray Medical, Inc.
Richland, WA, US
Received
July 8, 2011
Decision date
August 5, 2011
Decision
Substantially Equivalent (SESE)
Type
Special 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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More from Isoray Medical, Inc.

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K202267Sirius MRI Markers, Cs-131 Preloaded Strands with Sirius MRI Markers in 18 Gauge NeedlesKXK · Traditional 12/31/2020SE
K180515GammaTileKXK · Traditional 07/06/2018SE
K092458Proxcelan CS-131PRELOADED Strands, Model PL-1, Proxcelan CS-131 Preloaded Strands in 18…KXK · Special 08/28/2009SE
K092136Proxcelan CS-131 Preloaded Braided Strands, Model: PL-5KXK · Special 08/07/2009SE

Questions and answers

When was Gliasite RTS cleared by the FDA?

Gliasite RTS (K111931) received a 510(k) decision of Substantially Equivalent on August 5, 2011, 28 days after the submission was received.

What is the product code of K111931?

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