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BrachySource™, SourceCap™ 1251CSRAF

by Bard Brachytherapy, Inc

BrachySource, SourceCap 1251CSRAF is a manual brachytherapy source (FDA Class II; FDA product code KXK, Source, brachytherapy, radionuclide) made by Bard Brachytherapy, Inc, cleared under FDA 510(k) K140856 on 2 May 2014 and listed in FDA GUDID since 5 Oct 2015 (UDI-DI 00801741078286), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K140856

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00801741078286 UDI-DI Date5 Oct 2015ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK140856 Date2 May 2014DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K140856 decided 2 May 2014 Active
  • FDA GUDID UDI-DI 00801741078286 listed 5 Oct 2015 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K140856
  2. Listed FDA GUDID 00801741078286

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
BrachySource™, SourceCap™
Generic name
Manual brachytherapy source, permanent implant
Model / Ref / Catalog
1251CSRAF
Primary DI / UDI-DI
00801741078286
510(k) Number
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

Related devices

Category: General-purpose brachytherapy system applicator, manualManual brachytherapy source, permanent implantBrachytherapy source spacer

Cleared under the same submission (K140856)

Similar devices

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

Other devices from Bard Brachytherapy, Inc

See all devices from Bard Brachytherapy, Inc →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Prescription use
  • Convenience kit
  • Serial number
  • Expiration date
Other properties (8, all answered No)