Pharmaseed, Model BT-103-3

Q: What is the product code of K994016?

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

FDA 510(k) K994016 · Syncor Pharmaceuticals, Inc.

Substantially Equivalent

510(k) numberK994016

Submission

Device name: Pharmaseed, Model BT-103-3
Applicant: Syncor Pharmaceuticals, Inc.
Golden, CO, US
Received: November 26, 1999
Decision date: July 14, 2000
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) statement 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
K994018	Pharmaseed, Model BT-125-3KXK · Traditional	07/17/2000SE
K992007	Pharmaseed, Model BT-103-1KXK · Traditional	01/14/2000SE
K992008	Pharmaseed, Model BT-125-1KXK · Traditional	12/23/1999SE

Questions and answers

When was Pharmaseed, Model BT-103-3 cleared by the FDA?

Pharmaseed, Model BT-103-3 (K994016) received a 510(k) decision of Substantially Equivalent on July 14, 2000, 231 days after the submission was received.

What is the product code of K994016?

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