Cleared Traditional

K932676 - SPYROFILM IQ WOUND DRESSING(WITH INERT FILLER)

K932676 · Polymedica Industries, Inc. · General & Plastic Surgery device
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Dec 1993
Decision
191d
Days
-
Risk

K932676 is an FDA 510(k) clearance for the SPYROFILM IQ WOUND DRESSING(WITH INERT FILLER). Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Polymedica Industries, Inc. (Golden,, US). The FDA issued a Cleared decision on December 10, 1993 after a review of 191 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. 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 - K932676

510(k) Number K932676 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 02, 1993
Decision Date December 10, 1993
Days to Decision 191 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
76d slower than avg
Panel avg: 115d · This submission: 191d
Pathway characteristics
Predicate-based equivalence.

FRO Device Classification - Class 0,

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Peers - FRO Dressing, Wound, Drug

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K932676 · SPYROFILM IQ WOUND DRESSING(WITH INERT FILLER)
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