Cleared Traditional

BYRD EXTRACTOR SET (K893480) - FDA 510(k) Clearance

Class I General & Plastic Surgery device.

K893480 · Medical Engineering and Development Institute · General & Plastic Surgery device
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Jun 1989
Decision
50d
Days
Class 1
Risk

K893480 is an FDA 510(k) clearance for the BYRD EXTRACTOR SET. Classified as Dilator, Catheter (product code GCC), Class I - General Controls.

Submitted by Medical Engineering and Development Institute (West Lafayette, US). The FDA issued a Cleared decision on June 23, 1989 after a review of 50 days - a notably fast clearance 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: 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 K893480 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 04, 1989
Decision Date June 23, 1989
Days to Decision 50 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
65d faster than avg
Panel avg: 115d · This submission: 50d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code GCC Dilator, 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.