Cleared Traditional

NEUROLOGICAL SPONGE ON PLASTIC STICK (K833734) - FDA 510(k) Clearance

K833734 · American Medical Disposable, Inc. · Neurology device
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Apr 1984
Decision
181d
Days
-
Risk

K833734 is an FDA 510(k) clearance for the NEUROLOGICAL SPONGE ON PLASTIC STICK.

Submitted by American Medical Disposable, Inc. (Walker, US). The FDA issued a Cleared decision on April 23, 1984 after a review of 181 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. 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 American Medical Disposable, Inc. devices

Submission Details

510(k) Number K833734 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 25, 1983
Decision Date April 23, 1984
Days to Decision 181 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
33d slower than avg
Panel avg: 148d · This submission: 181d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -