Cleared Traditional

K964398 - SPYROFLEX PIGMENTED WOUND DRESSING/SPYROFLEX WOUND DRESSING TINTED

K964398 · Polymedica Industries, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 1997
Decision
354d
Days
-
Risk

K964398 is an FDA 510(k) clearance for the SPYROFLEX PIGMENTED WOUND DRESSING/SPYROFLEX WOUND DRESSING TINTED. Classified as Dressing, Wound And Burn, Occlusive (product code MGP).

Submitted by Polymedica Industries, Inc. (Golden,, US). The FDA issued a Cleared decision on October 24, 1997 after a review of 354 days - an unusually long review period, suggesting complex equivalence evaluation.

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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K964398

510(k) Number K964398 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 04, 1996
Decision Date October 24, 1997
Days to Decision 354 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
239d slower than avg
Panel avg: 115d · This submission: 354d
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 76
Devices cleared under the same product code (MGP) and FDA review panel - the closest regulatory comparables to K964398.
N-TERFACE
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K973036 · 3M Healthcare · Nov 1997
TRANSPARENT FILM DRESSING, INTELLIGENT FILM DRESSING
K973312 · Innovative Technologies , Ltd. · Oct 1997
HYDRASORB STERILE DRESSING
K973260 · Avitar, Inc. · Oct 1997
LYOCELL WOUND DRESSING/SURGICAL SPONGE
K972458 · Courtaulds Fibers, Inc. · Sep 1997
K964398 · SPYROFLEX PIGMENTED WOUND DRESSING/SPYROFLEX WOUND DRESSING TINTED
Download PDF FDA Summary Polymedica Industries…