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TheraSeed® TS200K

by Bard Brachytherapy, Inc

TheraSeed TS200K 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) K010283 on 26 Apr 2001 and listed in FDA GUDID since 5 Oct 2015 (UDI-DI 00801741078477), 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) K010283

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 Number00801741078477 UDI-DI Date5 Oct 2015ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK010283 Date26 Apr 2001DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K010283 decided 26 Apr 2001 Active
  • FDA GUDID UDI-DI 00801741078477 listed 5 Oct 2015 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K010283
  2. Listed FDA GUDID 00801741078477

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
TheraSeed®
Generic name
Manual brachytherapy source, permanent implant
Model / Ref / Catalog
TS200K
Primary DI / UDI-DI
00801741078477
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

Related devices

Category: Manual brachytherapy source, permanent implant

Cleared under the same submission (K010283)

and 8 more cleared under K010283

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

  • Sterilise before use
  • Single use
  • Implantable
  • Prescription use
  • Serial number
  • Expiration date
Other properties (9, all answered No)