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EndoSound® EVS Probe 5101

by Endosound, Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

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 Number00850050934233 UDI-DIDate1 Jun 2026ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
EndoSound® EVS Probe
Generic Name
Flexible endoscopic ultrasound imaging transducer
Model / Ref / Catalog
5101
Primary DI / UDI-DI
00850050934233
510(k) Number
FDA Product Code
ITX
GMDN Term
Flexible endoscopic ultrasound imaging transducer
Device Class
Class II
Regulation Number
892.1570
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K232518)

Show all (12)

Other devices from Endosound, Inc.

See all devices from Endosound, Inc. →

Properties

  • Prescription Use
  • Serial Number
  • Manufacturing Date

Other properties (11)

  • 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
  • Lot / Batch Number: No
  • Expiration Date: No