Cleared Traditional

K043526 - SILVERSEAL TUBULAR WOUND DRESSING WITH X-STATIC

K043526 is an FDA 510(k) clearance for SILVERSEAL TUBULAR WOUND DRESSING WITH ..., manufactured by Noble Fiber Technologies, Inc.. The device is a Class 1 Orthopedic device with product code LGF cleared through the Traditional 510(k) pathway after a 79-day FDA review.

K043526 · Noble Fiber Technologies, Inc. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K043526

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
43d faster than avg
Panel avg: 122d · This submission: 79d
Pathway characteristics
Predicate-based equivalence.

LGF Device Classification - Class 1, General Controls

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.

Regulatory Peers - LGF Component, Cast

All 22
Devices cleared under the same product code (LGF) and FDA review panel - the closest regulatory comparables to K043526.
CLINITEX STOCKINETTE
K973417 · Clinitex Medical Corp. · Dec 1997
CLINITEX CAST PADDING
K973420 · Clinitex Medical Corp. · Dec 1997
PROTEC COTTON PADDING BANDAGE
K955320 · Derivadas Degasa S.A. DE C.V. · Jan 1996
QUICK-CAST IMMOBILIZER
K932507 · Landec Corp. · Feb 1994
CARAPACE STERILE CAST PADDING
K931672 · Carapace, Inc. · Dec 1993
ARTIFLEX(TM)
K910274 · Beiersdorf, Inc. · Mar 1991
K043526 · SILVERSEAL TUBULAR WOUND DRESSING WITH X-STATIC
Download PDF FDA Summary Noble Fiber Technolog…