Cleared Traditional

TRANSPARENT DRESSING (K943111) - FDA 510(k) Clearance

K943111 · Acutek Adhesive Specialties, Inc. · General & Plastic Surgery device
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Sep 1994
Decision
77d
Days
-
Risk

K943111 is an FDA 510(k) clearance for the TRANSPARENT DRESSING. Classified as Dressing, Wound And Burn, Occlusive (product code MGP).

Submitted by Acutek Adhesive Specialties, Inc. (Inglewood, US). The FDA issued a Cleared decision on September 12, 1994 after a review of 77 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 Acutek Adhesive Specialties, Inc. devices

Submission Details

510(k) Number K943111 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received June 27, 1994
Decision Date September 12, 1994
Days to Decision 77 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
38d faster than avg
Panel avg: 115d · This submission: 77d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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