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BrachySource™ 1251PAPF

by Bard Brachytherapy, Inc

BrachySource 1251PAPF is a brachytherapy injection needle (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 00801741098611), active as of 22 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 22 Oct 2026

Documents

510(k) K140856

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00801741098611 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 00801741098611 listed 5 Oct 2015 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K140856
  2. Listed FDA GUDID 00801741098611

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  • Withdrawn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
Brachytherapy injection needle
Model / Ref / Catalog
1251PAPF
Primary DI / UDI-DI
00801741098611
510(k) Number
FDA product code
KXK
GMDN term
Brachytherapy injection needle
Device class
Class II
Regulation number
892.5730
GUDID distribution status
In Commercial Distribution
MRI safety
MR Conditional

Related devices

Category: Brachytherapy injection needleManual 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
  • Prescription use
  • Convenience kit
  • Serial number
  • Expiration date
Other properties (9, all answered No)