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NeuroProbe Non-shielded

by Alpha Omega Engineering Corp. 28 variants

NeuroProbe Non-shielded (366-001079-00) is a Class II device made by Alpha Omega Engineering Corp., cleared under FDA 510(k) K052527 on 12 Apr 2006 and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 07290016450385), active as of 23 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 23 Oct 2026

Documents

510(k) K052527

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number07290016450385 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK052527 Date12 Apr 2006DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K052527 decided 12 Apr 2006 Active
  • FDA GUDID UDI-DI 07290016450385 listed 24 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K052527
  2. Listed FDA GUDID 07290016450385

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
NeuroProbe
Generic name
Depth electrode
Model / Ref / Catalog
Non-shielded, 366-001079-00
Primary DI / UDI-DI
07290016450385
510(k) Number
FDA product code
GZL
GMDN term
Depth electrode
Device class
Class II
Regulation number
882.1330
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization
MRI safety
MR Unsafe

Related devices

Category: Depth electrode

Cleared under the same submission (K052527)

and 8 more cleared under K052527

Similar devices

Other devices filed under FDA product code GZL (Electrode, Depth).

Other devices from Alpha Omega Engineering Corp.

See all devices from Alpha Omega Engineering Corp. →

Properties

  • Sterilise before use
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (10, all answered No)