Cleared Traditional

RAYON NEUROLOGICAL SPONGE (K902921) - FDA 510(k) Clearance

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

K902921 · American Silk Sutures, Inc. · Neurology device
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Sep 1990
Decision
77d
Days
Class 2
Risk

K902921 is an FDA 510(k) clearance for the RAYON NEUROLOGICAL SPONGE. Classified as Neurosurgical Paddie (product code HBA), Class II - Special Controls.

Submitted by American Silk Sutures, Inc. (Lynn, US). The FDA issued a Cleared decision on September 18, 1990 after a review of 77 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.4700 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all American Silk Sutures, Inc. devices

Submission Details

510(k) Number K902921 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 03, 1990
Decision Date September 18, 1990
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. No clinical trials required.

Device Classification

Product Code HBA Neurosurgical Paddie
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.4700
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.