Cleared Traditional

K102478 - OTC ELASTO-GEL MANUKA HONEY WOUND DRESSING

K102478 · Southwest Technologies, Inc. · General & Plastic Surgery device
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Nov 2010
Decision
65d
Days
-
Risk

K102478 is an FDA 510(k) clearance for the OTC ELASTO-GEL MANUKA HONEY WOUND DRESSING. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Southwest Technologies, Inc. (Kansas City, US). The FDA issued a Cleared decision on November 3, 2010 after a review of 65 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 Southwest Technologies, Inc. devices

Submission Details

510(k) Number K102478 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 30, 2010
Decision Date November 03, 2010
Days to Decision 65 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
50d faster than avg
Panel avg: 115d · This submission: 65d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Peers - FRO Dressing, Wound, Drug

All 222
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