Cleared Traditional

AMERIGEL OINTMENT (K970133) - FDA 510(k) Clearance

K970133 · Amerx Health Care Corp. · General & Plastic Surgery device
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Apr 1997
Decision
89d
Days
-
Risk

K970133 is an FDA 510(k) clearance for the AMERIGEL OINTMENT. Classified as Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic (product code MGQ).

Submitted by Amerx Health Care Corp. (Clearwater, US). The FDA issued a Cleared decision on April 14, 1997 after a review of 89 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 Amerx Health Care Corp. devices

Submission Details

510(k) Number K970133 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received January 15, 1997
Decision Date April 14, 1997
Days to Decision 89 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
26d faster than avg
Panel avg: 115d · This submission: 89d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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