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SourceLink™ 7030550

by Bard Brachytherapy, Inc

SourceLink 7030550 is a brachytherapy source spacer (FDA Class II; FDA product code KXK, Source, brachytherapy, radionuclide) made by Bard Brachytherapy, Inc, cleared under FDA 510(k) K023210 on 28 Mar 2003 and listed in FDA GUDID since 6 Aug 2020 (UDI-DI 10801741184137), 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) K023210

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 Number10801741184137 UDI-DI Date6 Aug 2020ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK023210 Date28 Mar 2003DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K023210 decided 28 Mar 2003 Active
  • FDA GUDID UDI-DI 10801741184137 listed 6 Aug 2020 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K023210
  2. Listed FDA GUDID 10801741184137

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
SourceLink™
Generic name
Brachytherapy source spacer
Model / Ref / Catalog
7030550
Primary DI / UDI-DI
10801741184137
510(k) Number
FDA product code
KXK
GMDN term
Brachytherapy source spacer
Device class
Class II
Regulation number
892.5730
GUDID distribution status
In Commercial Distribution
Size
Length — 5 Millimeter

Related devices

Category: Brachytherapy source spacer

Cleared under the same submission (K023210)

and 6 more cleared under K023210

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
  • Lot / batch number
  • Expiration date
Other properties (9, all answered No)