Cleared Traditional

CUSH ISLAND DRESSING (K943424) - FDA 510(k) Clearance

K943424 · Cush Medical Products · General & Plastic Surgery device
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Oct 1994
Decision
80d
Days
-
Risk

K943424 is an FDA 510(k) clearance for the CUSH ISLAND DRESSING. Classified as Dressing, Wound And Burn, Occlusive (product code MGP).

Submitted by Cush Medical Products (Piney Flats, US). The FDA issued a Cleared decision on October 3, 1994 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.

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Submission Details

510(k) Number K943424 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received July 15, 1994
Decision Date October 03, 1994
Days to Decision 80 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
35d faster than avg
Panel avg: 115d · This submission: 80d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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