X-Pac EI3201
by Expanding Innovations, Inc.
X-Pac EI3201 is a Class II device made by Expanding Innovations, Inc., cleared under FDA 510(k) K250602 on 20 May 2025 and listed in FDA GUDID since 19 Sep 2025 (UDI-DI 00850041805559), 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 | Number00850041805559 | Date19 Sep 2025 | StatusListed |
| United States | FDA 510(k)SESE | NumberK250602 | Date20 May 2025 | StatusActive |
Official records
- AccessGUDID record 00850041805559
- FDA 510(k) database K250602
Across registries
- FDA 510(k) K250602 decided 20 May 2025 Active
- FDA GUDID UDI-DI 00850041805559 listed 19 Sep 2025 Listed
Timeline
- Cleared FDA 510(k) K250602
- Listed FDA GUDID 00850041805559
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- X-Pac
- Generic name
- Surgical instrument interim-placement holder, reusable
- Model / reference
- EI3201
- Primary DI / UDI-DI
- 00850041805559
- 510(k) Number
- FDA product code
- KCT
- GMDN term
- Surgical instrument interim-placement holder, reusable
- Device class
- Class II
- Regulation number
- 880.6850
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
Similar devices in this category
Other devices filed under Surgical instrument interim-placement holder, reusable.