Cleared Traditional

K926207 - MEDTRAX PACKING STRIP

K926207 · Medtrax Industries, Inc. · General & Plastic Surgery device
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May 1993
Decision
154d
Days
-
Risk

K926207 is an FDA 510(k) clearance for the MEDTRAX PACKING STRIP. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Medtrax Industries, Inc. (Longwood, US). The FDA issued a Cleared decision on May 12, 1993 after a review of 154 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.

View all Medtrax Industries, Inc. devices

FDA 510(k) Submission Details - K926207

510(k) Number K926207 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 09, 1992
Decision Date May 12, 1993
Days to Decision 154 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
39d slower than avg
Panel avg: 115d · This submission: 154d
Pathway characteristics
Predicate-based equivalence.

FRO Device Classification - Class 0,

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Peers - FRO Dressing, Wound, Drug

All 594
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