CIT Ortho 613034706
by Cit Ortho
CIT Ortho 613034706 is a Class II device made by Cit Ortho, cleared under FDA 510(k) K203526 on 12 Jan 2021 and listed in FDA GUDID since 23 Apr 2021 (UDI-DI 00850009724038), active as of 23 Oct 2026. 2 FDA recalls are linked to it.
Active
Valid until
No expiry
FDA recalls
2 ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00850009724038 | Date23 Apr 2021 | StatusListed |
| United States | FDA 510(k)SESE | NumberK203526 | Date12 Jan 2021 | StatusActive |
Official records
- AccessGUDID record 00850009724038
- FDA 510(k) database K203526
Across registries
- FDA 510(k) K203526 decided 12 Jan 2021 Active
- FDA GUDID UDI-DI 00850009724038 listed 23 Apr 2021 Listed
Recalls
-
- Ongoing Z-1453-2025
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues have been identified that may pose a risk to patient health.
-
- Ongoing Z-3053-2024
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.
Timeline
- Cleared FDA 510(k) K203526
- Listed FDA GUDID 00850009724038
- Recall initiated FDA recalls Z-3053-2024
- Recall initiated FDA recalls Z-1453-2025
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- CIT Ortho
- Generic name
- Rigid optical arthroscope, single-use
- Model / reference
- 613034706
- Primary DI / UDI-DI
- 00850009724038
- 510(k) Number
- FDA product code
- HRX
- GMDN term
- Rigid optical arthroscope, single-use
- Device class
- Class II
- Regulation number
- 888.1100
- GUDID distribution status
- In Commercial Distribution
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