Cleared Traditional

K930763 - FIGLEAF SHIELD

K930763 is an FDA 510(k) clearance for FIGLEAF SHIELD, manufactured by Byers Industries, Inc.. The device is a Class 1 Radiology device with product code IWT cleared through the Traditional 510(k) pathway after a 94-day FDA review.

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

FDA 510(k) Submission Details - K930763

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.

IWT Device Classification - Class 1, General Controls

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.