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TheraSeed XX65xN

by Theragenics Corp.

Ref XX6510N, XX6515N, XX6520NModel Loaded C20 in TPSII Individual - 10, 15, or 20 seeds per magazine - STERILE

TheraSeed XX65xN is a manual brachytherapy source (EU AIMDD; FDA Class II; FDA product code KXK, Source, Brachytherapy, Radionuclide) made by Theragenics Corp., registered in EUDAMED on 7 Aug 2026 (Basic UDI-DI B-00813787020631), cleared under FDA 510(k) K010283 on 26 Apr 2001 and listed in FDA GUDID since 21 Sep 2015 (UDI-DI 00813787020631), active as of 24 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE AIMDD 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K010283

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/AIMDD EUDAMED NumberB-00813787020631 Basic UDI-DI 00813787020631UDI-DIDate7 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00813787020631 UDI-DI Date21 Sep 2015ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK010283 Date26 Apr 2001DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-00813787020631 registered 7 Aug 2026 Active
  • FDA 510(k) K010283 decided 26 Apr 2001 Active
  • FDA GUDID UDI-DI 00813787020631 listed 21 Sep 2015 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K010283
  2. Listed FDA GUDID 00813787020631
  3. Registered EUDAMED B-00813787020631

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/AIMDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
TheraSeed® Pd-103 Implants: Up to 20 seeds, loaded in a C20 magazine - STERILE EUDAMED
TheraSeed GUDID
Generic name
Manual brachytherapy source, permanent implant
Device name
TheraSeed® Pd-103 Implants, Loose and Magazine Loaded Seed
Model / reference
Loaded C20 in TPSII Individual - 10 EUDAMED
15 EUDAMED
or 20 seeds per magazine - STERILE EUDAMED
XX6510N EUDAMED
XX6515N EUDAMED
XX6520N EUDAMED
XX65xN GUDID
Primary DI / UDI-DI
00813787020631
Basic UDI-DI
B-00813787020631
510(k) Number
FDA product code
KXK
EMDN code
J0501 Brachytherapy sources
GMDN term
Manual brachytherapy source, permanent implant
Device class
Class AIMDD EUDAMED
Class II GUDID
Regulation number
892.5730
EU registration type
Legacy device (under a directive)
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization
MRI safety
MR Conditional

Truth per registry

2 sources · 3 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
Loaded C20 in TPSII Individual - 10, 15, or 20 seeds per magazine - STERILE
XX6510N, XX6515N, XX6520N
GUDID
XX65xN
Device classEUDAMED
Class AIMDD
GUDID
Class II
Sterilise before useEUDAMED
No
GUDID
Yes

Registry differences

EUDAMED and FDA GUDID describe the same product (same UDI-DI) and state different values:

  • Sterilise before use UDI-DI 00813787020631: EUDAMED states No, FDA GUDID states Yes.

Device class is stated on each registry's own scale: Class AIMDD in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

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

  • Supplied sterile
  • Sterilise before use NoEUDAMEDYesGUDID
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (16, all answered No)