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Gold Marker GM1033

by Riverpoint Medical LLC

Gold Marker GM1033 is a Class II device made by Riverpoint Medical LLC, cleared under FDA 510(k) K103449 on 25 Feb 2011 and listed in FDA GUDID since 26 Mar 2020 (UDI-DI 00810020083132), 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) K103449

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 Number00810020083132 UDI-DI Date26 Mar 2020ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Abbreviated NumberK103449 Date25 Feb 2011DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K103449 decided 25 Feb 2011 Active
  • FDA GUDID UDI-DI 00810020083132 listed 26 Mar 2020 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K103449
  2. Listed FDA GUDID 00810020083132

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Gold Marker
Generic name
Manual brachytherapy source, permanent implant
Model / reference
GM1033
Primary DI / UDI-DI
00810020083132
510(k) Number
FDA product code
NEU
GMDN term
Manual brachytherapy source, permanent implant
Device class
Class II
Regulation number
878.4300
GUDID distribution status
In Commercial Distribution

Related devices

Category: Manual brachytherapy source, permanent implant

Cleared under the same submission (K103449)

and 8 more cleared under K103449

Similar devices

Other devices filed under FDA product code NEU (Marker, Radiographic, Implantable).

Other devices from Riverpoint Medical LLC

See all devices from Riverpoint Medical LLC →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (9, all answered No)