Cleared Traditional

LYOCELL WOUND DRESSING/SURGICAL SPONGE (K972458) - FDA 510(k) Clearance

K972458 · Courtaulds Fibers, Inc. · General & Plastic Surgery device
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Sep 1997
Decision
80d
Days
-
Risk

K972458 is an FDA 510(k) clearance for the LYOCELL WOUND DRESSING/SURGICAL SPONGE. Classified as Dressing, Wound And Burn, Occlusive (product code MGP).

Submitted by Courtaulds Fibers, Inc. (Axis, US). The FDA issued a Cleared decision on September 19, 1997 after a review of 80 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery 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: 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 Courtaulds Fibers, Inc. devices

Submission Details

510(k) Number K972458 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 1997
Decision Date September 19, 1997
Days to Decision 80 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
35d faster than avg
Panel avg: 115d · This submission: 80d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code MGP Dressing, Wound And Burn, Occlusive
Device Class -