Cleared Traditional

UNI-SITE (K953018) - FDA 510(k) Clearance

K953018 · Ttl Medical · General & Plastic Surgery device
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Sep 1995
Decision
71d
Days
-
Risk

K953018 is an FDA 510(k) clearance for the UNI-SITE. Classified as Dressing, Wound And Burn, Occlusive (product code MGP).

Submitted by Ttl Medical (Knoxville, US). The FDA issued a Cleared decision on September 8, 1995 after a review of 71 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.

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Submission Details

510(k) Number K953018 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 29, 1995
Decision Date September 08, 1995
Days to Decision 71 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
44d faster than avg
Panel avg: 115d · This submission: 71d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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