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TheraSeed XX200

by Theragenics Corp.

TheraSeed XX200 is a manual brachytherapy source (FDA Class II; FDA product code KXK, Source, Brachytherapy, Radionuclide) made by Theragenics Corp., cleared under FDA 510(k) K010283 on 26 Apr 2001 and listed in FDA GUDID since 21 Sep 2015 (UDI-DI 00813787020006), 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) K010283

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 Number00813787020006 UDI-DI Date21 Sep 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 00813787020006 listed 21 Sep 2015 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K010283
  2. Listed FDA GUDID 00813787020006

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  • Withdrawn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 / reference
XX200
Primary DI / UDI-DI
00813787020006
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
Sterilisation method
Moist Heat or Steam Sterilization
MRI safety
MR Conditional

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 Theragenics Corp.

See all devices from Theragenics Corp. →

Properties

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