Cleared Traditional

K930763 - FIGLEAF SHIELD (FDA 510(k) Clearance)

Class I Radiology device.

K930763 · Byers Industries, Inc. · Radiology device
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May 1993
Decision
94d
Days
Class 1
Risk

K930763 is an FDA 510(k) clearance for the FIGLEAF SHIELD. Classified as Shield, Gonadal (product code IWT), Class I - General Controls.

Submitted by Byers Industries, Inc. (Portland, US). The FDA issued a Cleared decision on May 17, 1993 after a review of 94 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.6500 - the FDA radiology and imaging software oversight 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 Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Byers Industries, Inc. devices

Submission Details

510(k) Number K930763 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 12, 1993
Decision Date May 17, 1993
Days to Decision 94 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
13d faster than avg
Panel avg: 107d · This submission: 94d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code IWT Shield, Gonadal
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 892.6500
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.