Proxcelan CS-131 Preloaded Braided Strands, Model: PL-5

Q: What is the product code of K092136?

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

FDA 510(k) K092136 · Isoray Medical, Inc.

Substantially Equivalent

510(k) numberK092136

Submission

Device name: Proxcelan CS-131 Preloaded Braided Strands, Model: PL-5
Applicant: Isoray Medical, Inc.
Richland, WA, US
Received: July 15, 2009
Decision date: August 7, 2009
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

Other 510(k)s with product code KXK

510(k)	Device	Applicant	Decision
K252296	OncoPatchKXK · Traditional	Oncopatch, Inc.	12/05/2025SE
K242818	IsoSphereKXK · Traditional	Isoaid, LLC	07/15/2025SE
K223465	RadianceTx Radionuclide Brachytherapy SourceKXK · Traditional	Radiance Therapeutics, Inc.	01/11/2023SE
K221539	GammaTileKXK · Traditional	Gt Medical Technologies	11/09/2022SE
K202267	Sirius MRI Markers, Cs-131 Preloaded Strands with Sirius MRI Markers in 18 Gauge NeedlesKXK · Traditional	Isoray Medical, Inc.	12/31/2020SE
K193602	LV Liberty Vision Model 1 90Yttrium Brachytherapy SourceKXK · Special	Lv Liberty Vision Corporation	05/29/2020SE
K190839	GammaTileKXK · Traditional	Gt Medical Technologies	01/23/2020SE
K191324	CivaDermKXK · Traditional	Civatech Oncology, Inc.	09/20/2019SE
K190296	GammaTileKXK · Special	Gt Medical Technologies	03/13/2019SE
K180515	GammaTileKXK · Traditional	Isoray Medical, Inc.	07/06/2018SE

More from Isoray Medical, Inc.

510(k)	Device	Decision
K202267	Sirius MRI Markers, Cs-131 Preloaded Strands with Sirius MRI Markers in 18 Gauge NeedlesKXK · Traditional	12/31/2020SE
K180515	GammaTileKXK · Traditional	07/06/2018SE
K111931	Gliasite RTSKXK · Special	08/05/2011SE
K092458	Proxcelan CS-131PRELOADED Strands, Model PL-1, Proxcelan CS-131 Preloaded Strands in 18…KXK · Special	08/28/2009SE

Questions and answers

When was Proxcelan CS-131 Preloaded Braided Strands, Model: PL-5 cleared by the FDA?

Proxcelan CS-131 Preloaded Braided Strands, Model: PL-5 (K092136) received a 510(k) decision of Substantially Equivalent on August 7, 2009, 23 days after the submission was received.

What is the product code of K092136?

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