BrachySource™, SourceCap™ 1251PAF

• FDA 510(k) K140856 decided 2 May 2014 Active
• FDA GUDID UDI-DI 00801741098581 listed 5 Oct 2015 Listed

1. 2 May 2014 Cleared FDA 510(k) K140856
2. 5 Oct 2015 Listed FDA GUDID 00801741098581

Trade name

BrachySource™, SourceCap™

Generic name

Manual brachytherapy source, permanent implant

Model / Ref / Catalog

1251PAF

Primary DI / UDI-DI

00801741098581

510(k) Number

K140856 ↗

FDA product code

KXK

GMDN term

Manual brachytherapy source, permanent implant

Device class

Class II

Regulation number

892.5730

GUDID distribution status

In Commercial Distribution

MRI safety

MR Conditional

Category: Brachytherapy injection needle,Manual brachytherapy source, permanent implant,Brachytherapy source spacer

Other devices filed under FDA product code KXK (Source, brachytherapy, radionuclide).

• INTERSOURCE 125, MODEL 1251L by International Brachytherapy S.A.
• IsoSphere by Isoaid, LLC
• CESIUM-131 STRAND, STRAND PRELOAD, PRELOAD, S-CARTRIDGE by Isoray, Inc.
• AOS MARKER SEEDS by ALPHA-OMEGA SERVICES, INC.
• PROSTEC 125I BRANCHYTHERAPY SNAPSEED by Prostec, LLC
• TheraStrand® with I-Seed XX72xiL by THERAGENICS CORP.
• North American Scientific I-125 Radionuclide Brachytherapy Source Model MED 3631-A by Ml Strategies, Inc.
• TheraSeed XX500 by THERAGENICS CORP.
• Colab Cocath Implanted Catheter and Depot by Colab Intl., Inc.
• Accu-Space Plain Gut Absorbable Seeding Spacers by Cp Medical

• BrachySource™ PS1251LS

  Class II

  FDA 510(k) K093663 Active Cleared 23 Dec 2009 GUDID on market

• TheraSeed®, SourceLink™ 200LINKLS

  Class II

  FDA 510(k) K060636 Active Cleared 19 Apr 2006 GUDID on market

• QuickLink™, SourceLink™ 70302QC10

  Class II

  FDA 510(k) K023210 Active Cleared 28 Mar 2003 GUDID on market

• SourceLink™ 7030550

  Class II

  FDA 510(k) K023210 Active Cleared 28 Mar 2003 GUDID on market

See all devices from Bard Brachytherapy, Inc →