Cleared Traditional

K893123 - ADHESIVE BANDAGES & PADS FOR MINOR CUTS...

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

FDA 510(k) Submission Details - K893123

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.

QSY Device Classification - Class 0,

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