Cleared Traditional

Sterile LeadConfirm

K191739 · Alpha Omega Engineering , Ltd. · Neurology
Jan 2020
Decision
188d
Days
Class 2
Risk

About This 510(k) Submission

K191739 is an FDA 510(k) clearance for the Sterile LeadConfirm, a Electrode, Depth (Class II — Special Controls, product code GZL), submitted by Alpha Omega Engineering , Ltd. (Nazareth, IL). The FDA issued a Cleared decision on January 2, 2020, 188 days after receiving the submission on June 28, 2019. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1330.

Submission Details

510(k) Number K191739 FDA.gov
FDA Decision Cleared SESE
Date Received June 28, 2019
Decision Date January 02, 2020
Days to Decision 188 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code GZL — Electrode, Depth
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.1330

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