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BrachySource™ PS1251CS

by Bard Brachytherapy, Inc

BrachySource PS1251CS is a general-purpose brachytherapy system applicator (FDA Class II; FDA product code KXK, Source, brachytherapy, radionuclide) made by Bard Brachytherapy, Inc, cleared under FDA 510(k) K093663 on 23 Dec 2009 and listed in FDA GUDID since 5 Oct 2015 (UDI-DI 00801741078224), active as of 23 Oct 2026. One FDA recall is linked to it.

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

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

510(k) K093663

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 Number00801741078224 UDI-DI Date5 Oct 2015ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK093663 Date23 Dec 2009DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K093663 decided 23 Dec 2009 Active
  • FDA GUDID UDI-DI 00801741078224 listed 5 Oct 2015 Listed

Recalls

1 recall · FDA

    • Terminated Z-1702-2018 FDA Class II initiated 10 Apr 2018

    Bard Medical Division is recalling the BARD BrachySource Iodine125 Radioactive Seeds in Mick Applicators and BARD BrachySource Iodine125 Radioactive Seeds Loose in Vial with Sterile Spacers. Because the incorrect dosage level radioactive seeds were mixed up and sent to two hospitals. One Hospital ordered BrachySource Iodine125 0.36 mCi radioactive seeds but instead received BrachySource Iodine125 0.28 mCi radioactive seeds and vice versa for the other hospital affected.

Timeline

3 dated events

  1. Cleared FDA 510(k) K093663
  2. Listed FDA GUDID 00801741078224
  3. Recall initiated FDA recalls Z-1702-2018

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
BrachySource™
Generic name
General-purpose brachytherapy system applicator, manual
Model / Ref / Catalog
PS1251CS
Primary DI / UDI-DI
00801741078224
510(k) Number
FDA product code
KXK
GMDN term
General-purpose brachytherapy system applicator, manual
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 implant

Cleared under the same submission (K093663)

and 8 more cleared under K093663

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
  • Prescription use
  • Convenience kit
  • Serial number
  • Expiration date
Other properties (9, all answered No)