Paradigm 1200003
by Proprio
Paradigm 1200003 is a Class II device made by Proprio, cleared under FDA 510(k) K252950 on 15 Dec 2025 (3 earlier submissions) and listed in FDA GUDID since 5 May 2023 (UDI-DI 00850042604052), 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 | FDA 510(k)SESE | NumberK252950 | Date15 Dec 2025 | StatusActive |
| United States | GUDID listing | Number00850042604052 | Date5 May 2023 | StatusListed |
Official records
- AccessGUDID record 00850042604052
- FDA 510(k) database K252950
- FDA 510(k) database K250879
- FDA 510(k) database K243258
- FDA 510(k) database K222291
Across registries
- FDA 510(k) K252950 decided 15 Dec 2025 Active
- FDA GUDID UDI-DI 00850042604052 listed 5 May 2023 Listed
Timeline
- Cleared FDA 510(k) K222291
- Listed FDA GUDID 00850042604052
- Cleared FDA 510(k) K243258
- Cleared FDA 510(k) K250879
- Cleared FDA 510(k) K252950
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Paradigm
- Generic name
- Abdominal/ENT/orthopaedic surgical probe, reusable
- Model / Ref / Catalog
- 1200003
- Primary DI / UDI-DI
- 00850042604052
- FDA product code
- OLO
- GMDN term
- Abdominal/ENT/orthopaedic surgical probe, reusable
- Device class
- Class II
- Regulation number
- 882.4560
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
Similar devices in this category
Other devices filed under Abdominal/ENT/orthopaedic surgical probe, reusable.