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SOLOPASS 2.0 Ultrasound Cable Assembly 1

by Intravent Medical Partners, LP

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00860012211913 UDI-DI Date11 Dec 2025ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
SOLOPASS 2.0 Ultrasound Cable Assembly
Generic Name
Neurological stereotactic surgery system
Model / Ref / Catalog
1, CAB25-0000
Primary DI / UDI-DI
00860012211913
510(k) Number
FDA Product Code
IYN
GMDN Term
Neurological stereotactic surgery system
Device Class
Class II
Regulation Number
892.1550
GUDID distribution status
In Commercial Distribution
Sterilization Method
Hydrogen Peroxide

Related devices

Cleared under the same submission (K251317)

Other devices from Intravent Medical Partners, LP

Properties

  • Prescription Use
  • Lot / Batch Number
  • Serial Number
  • Manufacturing Date

Other properties (10)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Expiration Date: No