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Cannula Standard

by Alpha Omega Engineering Corp. 30 variants

Cannula Standard (STR-020121-00) is an intracerebral cannula (FDA Class II; FDA product code GZL, Electrode, Depth) made by Alpha Omega Engineering Corp., cleared under FDA 510(k) K120098 on 12 Jun 2012 and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 07290014954694), 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) K120098

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 Number07290014954694 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK120098 Date12 Jun 2012DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K120098 decided 12 Jun 2012 Active
  • FDA GUDID UDI-DI 07290014954694 listed 24 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K120098
  2. Listed FDA GUDID 07290014954694

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Cannula
Generic name
Intracerebral cannula, implantable
Model / Ref / Catalog
Standard, STR-020121-00
Primary DI / UDI-DI
07290014954694
510(k) Number
FDA product code
GZL
GMDN term
Intracerebral cannula, implantable
Device class
Class II
Regulation number
882.1330
GUDID distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Related devices

Category: Intracerebral cannula, implantable

Cleared under the same submission (K120098)

and 8 more cleared under K120098

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

  • Supplied sterile
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (9, all answered No)