Cleared Traditional

REFLEX(R) ECA (K924929) - FDA 510(k) Clearance

Class I General & Plastic Surgery device.

K924929 · Richard-Allan Medical · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
Jul 1993
Decision
294d
Days
Class 1
Risk

K924929 is an FDA 510(k) clearance for the REFLEX(R) ECA. Classified as Applier, Hemostatic Clip (product code HBT), Class I - General Controls.

Submitted by Richard-Allan Medical (Richland, US). The FDA issued a Cleared decision on July 21, 1993 after a review of 294 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4800 - 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 K924929 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 1992
Decision Date July 21, 1993
Days to Decision 294 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
179d slower than avg
Panel avg: 115d · This submission: 294d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HBT Applier, Hemostatic Clip
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4800
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.