Cleared Traditional

ADHESIVE BANDAGES & PADS FOR MINOR CUTS/SCRAPES (K893123) - FDA 510(k) Clearance

K893123 · Les Laboratorires Brothier, S.A. · General & Plastic Surgery device
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Feb 1990
Decision
294d
Days
-
Risk

K893123 is an FDA 510(k) clearance for the ADHESIVE BANDAGES & PADS FOR MINOR CUTS/SCRAPES. Classified as Hemostatic Wound Dressing Without Thrombin Or Other Biologics (product code QSY).

Submitted by Les Laboratorires Brothier, S.A. (Arlington, US). The FDA issued a Cleared decision on February 13, 1990 after a review of 294 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Les Laboratorires Brothier, S.A. devices

Submission Details

510(k) Number K893123 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 25, 1989
Decision Date February 13, 1990
Days to Decision 294 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
179d slower than avg
Panel avg: 115d · This submission: 294d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code QSY Hemostatic Wound Dressing Without Thrombin Or Other Biologics
Device Class -
Definition To Temporarily Control Bleeding And Cover External Wounds.