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Cervical Applicator Set 710746

by Icad, Inc.

Cervical Applicator Set 710746 (CG1000) is a Class II device made by Icad, Inc., cleared under FDA 510(k) K123442 on 27 Feb 2013 and listed in FDA GUDID since 20 Sep 2016 (UDI-DI 00858012005557), 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) K123442

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 Number00858012005557 UDI-DI Date20 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK123442 Date27 Feb 2013DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K123442 decided 27 Feb 2013 Active
  • FDA GUDID UDI-DI 00858012005557 listed 20 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K123442
  2. Listed FDA GUDID 00858012005557

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Cervical Applicator Set
Generic name
Cervical/intrauterine brachytherapy system applicator, manual
Model / Ref / Catalog
710746, CG1000
Primary DI / UDI-DI
00858012005557
510(k) Number
FDA product code
JAQ
GMDN term
Cervical/intrauterine brachytherapy system applicator, manual
Device class
Class II
Regulation number
892.5700
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization
MRI safety
MR Safe

Similar devices

Other devices filed under FDA product code JAQ (System, Applicator, Radionuclide, Remote-Controlled).

Other devices from Icad, Inc.

See all devices from Icad, Inc. →

Properties

  • Sterilise before use
  • Serial number
  • Manufacturing date
Other properties (12, all answered No)