Cleared Traditional

K972458 - LYOCELL WOUND DRESSING/SURGICAL SPONGE

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

FDA 510(k) Submission Details - K972458

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
35d faster than avg
Panel avg: 115d · This submission: 80d
Pathway characteristics
Predicate-based equivalence.

MGP Device Classification - Class 0,

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

Regulatory Peers - MGP Dressing, Wound And Burn, Occlusive

All 35
Devices cleared under the same product code (MGP) and FDA review panel - the closest regulatory comparables to K972458.
SPYROFLEX PIGMENTED WOUND DRESSING/SPYROFLEX WOUND DRESSING TINTED
K964398 · Polymedica Industries, Inc. · Oct 1997
TRANSPARENT FILM DRESSING, INTELLIGENT FILM DRESSING
K973312 · Innovative Technologies , Ltd. · Oct 1997
HYDRASORB STERILE DRESSING
K973260 · Avitar, Inc. · Oct 1997
OPPORTUNITY I.V. START KIT
K971093 · Opportunity, Inc. · Sep 1997
ALGOPLAQUE HYDROCOLLOID DRESSING
K970518 · Laboratoires Urgo S.A. · Mar 1997
NASP TRANSPARENT DRESSING
K963753 · North American Sterilization & Packaging Co. · Nov 1996