Cleared Traditional

K854266 - STERILE LASER RESISTANT SURGICAL FIELD DRAPE (FDA 510(k) Clearance)

K854266 · Lasersafe, Inc. · General & Plastic Surgery device
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Mar 1986
Decision
155d
Days
-
Risk

K854266 is an FDA 510(k) clearance for the STERILE LASER RESISTANT SURGICAL FIELD DRAPE.

Submitted by Lasersafe, Inc. (Pittsburgh, US). The FDA issued a Cleared decision on March 27, 1986 after a review of 155 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.

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Submission Details

510(k) Number K854266 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 23, 1985
Decision Date March 27, 1986
Days to Decision 155 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
41d slower than avg
Panel avg: 114d · This submission: 155d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -