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Hummingbird® H610MR

by Innerspace Neuro Solutions, Inc.

Listed FDA GUDID listing, not in commercial distribution

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 Number00851680007182 UDI-DI Date28 Nov 2016ListedStatusListed GUDID: not 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  • Withdrawn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
Hummingbird®
Generic Name
Intracerebral sensor catheter, short-term
Model / Ref / Catalog
H610MR
Primary DI / UDI-DI
00851680007182
510(k) Number
FDA Product Code
GWM
GMDN Term
Intracerebral sensor catheter, short-term
Device Class
Class II
Regulation Number
882.1620
GUDID distribution status
Not in Commercial Distribution
MRI Safety
MR Conditional
Size
Catheter Gauge — 8.5 French

Related devices

Cleared under the same submission (K083378)

Other devices from Innerspace Neuro Solutions, Inc.

Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (9)

  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No