Cleared Traditional

K833734 - NEUROLOGICAL SPONGE ON PLASTIC STICK

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

FDA 510(k) Submission Details - K833734

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
33d slower than avg
Panel avg: 148d · This submission: 181d
Pathway characteristics
Predicate-based equivalence.

Device Classification - Class ,

Product Code -
Device Class -