Cleared Traditional

EUTRA GEL FOR WOUND DRESSING (K932291) - FDA 510(k) Clearance

K932291 · Swiss American Products, Inc. · General & Plastic Surgery device
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Jul 1994
Decision
434d
Days
-
Risk

K932291 is an FDA 510(k) clearance for the EUTRA GEL FOR WOUND DRESSING. Classified as Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic (product code MGQ).

Submitted by Swiss American Products, Inc. (Dallas, US). The FDA issued a Cleared decision on July 18, 1994 after a review of 434 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General & Plastic Surgery submissions.

View all Swiss American Products, Inc. devices

Submission Details

510(k) Number K932291 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received May 10, 1993
Decision Date July 18, 1994
Days to Decision 434 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
319d slower than avg
Panel avg: 115d · This submission: 434d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code MGQ Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic
Device Class -