Cleared Traditional

K832916 - INIVOX ELECTRODE/CATHETER SYS (FDA 510(k) Clearance)

Class III device cleared through the 510(k) pathway via substantial equivalence to a legally marketed predicate.

K832916 · Critikon Company, LLC · Neurology device
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Nov 1983
Decision
77d
Days
Class 3
Risk

K832916 is an FDA 510(k) clearance for the INIVOX ELECTRODE/CATHETER SYS. Classified as Stimulator, Spinal-cord, Implanted For Peripheral Vascular Disease (product code LLE), Class III - Premarket Approval.

Submitted by Critikon Company, LLC (Mchenry, US). The FDA issued a Cleared decision on November 14, 1983 after a review of 77 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: High-complexity regulatory submission. High regulatory complexity profile. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Critikon Company, LLC devices

Submission Details

510(k) Number K832916 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 29, 1983
Decision Date November 14, 1983
Days to Decision 77 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
71d faster than avg
Panel avg: 148d · This submission: 77d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LLE Stimulator, Spinal-cord, Implanted For Peripheral Vascular Disease
Device Class Class 3 - Premarket Approval
What this classification means

Class III devices typically require Premarket Approval (PMA) with clinical evidence. Clearance through 510(k) for Class III devices is granted only when substantial equivalence to a valid predicate can be established.