Neuromed Model Oca-30 Octode and Model Sca-30

by Neuromed, Inc. 510(k)

Active United States

510(k) K921319

Regulatory status

as of 26 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK921319	Date5 May 1993Cleared	StatusActive

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not known
Not covered

United States — FDA 510(k) Active

Recalls: none on record (FDA, checked 22 Oct 2026)

Specification

510(k)

510(k) Number: K921319
FDA Product Code: GZB

Regulation: 21 CFR Part 882.5880
Advisory Committee: Neurology
FDA Decision: SESE Substantially Equivalent

Other devices from Neuromed, Inc.

Unistim Unt-1

Class II
Neuromed TS8 Test Stimulator

Class II
Introde Int-8

Class II
Neuromed Octrode Model Mnr-88B/88C Neurostim Syst

Class II
Multistim Laminectomy Electrode

Class II
Neuromed Model 1992 Ls Lamitrode Lead

Class II

See all devices from Neuromed, Inc. →