Cleared Traditional

K150800 - Valved Safety Centesis Catheter (FDA 510(k) Clearance)

Class I General & Plastic Surgery device.

K150800 · B.Braun Medical, Inc. · General & Plastic Surgery device
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Nov 2015
Decision
231d
Days
Class 1
Risk

K150800 is an FDA 510(k) clearance for the Valved Safety Centesis Catheter. Classified as Needle, Catheter (product code GCB), Class I - General Controls.

Submitted by B.Braun Medical, Inc. (Allentown, US). The FDA issued a Cleared decision on November 12, 2015 after a review of 231 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4200 - the FDA general and plastic surgery device framework. 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 K150800 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 26, 2015
Decision Date November 12, 2015
Days to Decision 231 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
117d slower than avg
Panel avg: 114d · This submission: 231d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code GCB Needle, Catheter
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4200
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.