Cleared Traditional

K964701 - MITRAFLEX PIGMENTED WOUND DRESSING

K964701 · Polymedica Industries, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1997
Decision
74d
Days
-
Risk

K964701 is an FDA 510(k) clearance for the MITRAFLEX PIGMENTED WOUND DRESSING. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Polymedica Industries, Inc. (Golden,, US). The FDA issued a Cleared decision on February 7, 1997 after a review of 74 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 Polymedica Industries, Inc. devices

FDA 510(k) Submission Details - K964701

510(k) Number K964701 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 25, 1996
Decision Date February 07, 1997
Days to Decision 74 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
41d faster than avg
Panel avg: 115d · This submission: 74d
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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