Cleared Traditional

AMERIGEL WOUND DRESSING PLUS 1/2 OZ. (15G TUBE), MODEL A2025 (K092086) - FDA 510(k) Clearance

Also marketed or referenced as:
1 OZ. (30G TUBE), MODEL A2026 3 OZ (90G TUBE),MODEL A2027
K092086 · Amerx Health Care Corp. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2009
Decision
21d
Days
-
Risk

K092086 is an FDA 510(k) clearance for the AMERIGEL WOUND DRESSING PLUS 1/2 OZ. (15G TUBE), MODEL A2025. Classified as Wound Dressings Containing Topical Analgesics (product code SEJ).

Submitted by Amerx Health Care Corp. (Clearwater, US). The FDA issued a Cleared decision on July 30, 2009 after a review of 21 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 K092086 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 09, 2009
Decision Date July 30, 2009
Days to Decision 21 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
94d faster than avg
Panel avg: 115d · This submission: 21d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code SEJ Wound Dressings Containing Topical Analgesics
Device Class -
Definition A Solid Wound Dressing Containing Topical Analgesics Is Used To Cover And Protect A Wound, To Absorb Exudate, To Maintain Appropriate Moisture Balance Within The Wound, And To Reduce Pain. A Wound Dressing Formulated As A Gel, Cream Or Ointment Containing Topical Analgesics Is Used To Maintain Appropriate Moisture Balance Within The Wound And To Reduce Pain.