Cleared Traditional

K811166 - SURGICAL DRESSING SET (FDA 510(k) Clearance)

K811166 · Washington-Greene County Branch Pennsylvania Assoc · General & Plastic Surgery device
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Jun 1981
Decision
35d
Days
-
Risk

K811166 is an FDA 510(k) clearance for the SURGICAL DRESSING SET.

Submitted by Washington-Greene County Branch Pennsylvania Assoc (Mchenry, US). The FDA issued a Cleared decision on June 2, 1981 after a review of 35 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 K811166 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 28, 1981
Decision Date June 02, 1981
Days to Decision 35 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
79d faster than avg
Panel avg: 114d · This submission: 35d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -