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X-Pac EI2467

by Expanding Innovations, Inc.

X-Pac EI2467 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 30 Jul 2026 (UDI-DI 00810166521628), 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) K250602

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 Number00810166521628 UDI-DI Date30 Jul 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK250602 Date20 May 2025DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K250602 decided 20 May 2025 Active
  • FDA GUDID UDI-DI 00810166521628 listed 30 Jul 2026 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K250602
  2. Listed FDA GUDID 00810166521628

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
X-Pac
Generic name
Surgical instrument interim-placement holder, reusable
Model / reference
EI2467
Primary DI / UDI-DI
00810166521628
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

Related devices

Cleared under the same submission (K250602)

and 8 more cleared under K250602

Other devices from Expanding Innovations, Inc.

See all devices from Expanding Innovations, Inc. →

Properties

  • Sterilise before use
  • Prescription use
  • Convenience kit
  • Lot / batch number
Other properties (11, all answered No)