Cervical Applicator Set, Bundle 2 710855
by Icad, Inc.
Cervical Applicator Set, Bundle 2 710855 (CG1002) 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 00858012005540), active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00858012005540 | Date20 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK123442 | Date27 Feb 2013 | StatusActive |
Official records
- AccessGUDID record 00858012005540
- FDA 510(k) database K123442
Across registries
- FDA 510(k) K123442 decided 27 Feb 2013 Active
- FDA GUDID UDI-DI 00858012005540 listed 20 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K123442
- Listed FDA GUDID 00858012005540
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Cervical Applicator Set, Bundle 2
- Generic name
- Cervical/intrauterine brachytherapy system applicator, manual
- Model / Ref / Catalog
- 710855, CG1002
- Primary DI / UDI-DI
- 00858012005540
- 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
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