Cleared Traditional

K043526 - SILVERSEAL TUBULAR WOUND DRESSING WITH X-STATIC (FDA 510(k) Clearance)

Class I Orthopedic device.

K043526 · Noble Fiber Technologies, Inc. · Orthopedic device
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Mar 2005
Decision
79d
Days
Class 1
Risk

K043526 is an FDA 510(k) clearance for the SILVERSEAL TUBULAR WOUND DRESSING WITH X-STATIC. Classified as Component, Cast (product code LGF), Class I - General Controls.

Submitted by Noble Fiber Technologies, Inc. (Clarks Summit, US). The FDA issued a Cleared decision on March 10, 2005 after a review of 79 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.5940 - the FDA orthopedic device regulatory 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 Noble Fiber Technologies, Inc. devices

Submission Details

510(k) Number K043526 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 21, 2004
Decision Date March 10, 2005
Days to Decision 79 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
43d faster than avg
Panel avg: 122d · This submission: 79d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LGF Component, Cast
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 888.5940
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.