Cleared Traditional

NOVA GAUZE(R) DISPOSABLE NONWOVEN SPONGES, STERILE (K915530) - FDA 510(k) Clearance

Class II Neurology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K915530 · American Threshold Industries, Inc. · Neurology device
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Aug 1992
Decision
251d
Days
Class 2
Risk

K915530 is an FDA 510(k) clearance for the NOVA GAUZE(R) DISPOSABLE NONWOVEN SPONGES, STERILE. Classified as Tong, Skull For Traction (product code HAX), Class II - Special Controls.

Submitted by American Threshold Industries, Inc. (Enka, US). The FDA issued a Cleared decision on August 17, 1992 after a review of 251 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5960 - the FDA neurology device framework. 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.

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Submission Details

510(k) Number K915530 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 10, 1991
Decision Date August 17, 1992
Days to Decision 251 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
103d slower than avg
Panel avg: 148d · This submission: 251d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HAX Tong, Skull For Traction
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5960
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Neurology devices follow this clearance model.