Cleared Traditional

K974327 - WINGED NEEDLE HOLDER (FDA 510(k) Clearance)

Class I Gastroenterology & Urology device.

K974327 · Phx Technologies Corp. · Gastroenterology & Urology device
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Jan 1998
Decision
52d
Days
Class 1
Risk

K974327 is an FDA 510(k) clearance for the WINGED NEEDLE HOLDER. Classified as Holder, Needle, Gastroenterologic (product code FHQ), Class I - General Controls.

Submitted by Phx Technologies Corp. (Denton, US). The FDA issued a Cleared decision on January 9, 1998 after a review of 52 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.4730 - the FDA gastroenterology and urology 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.

View all Phx Technologies Corp. devices

Submission Details

510(k) Number K974327 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 18, 1997
Decision Date January 09, 1998
Days to Decision 52 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
78d faster than avg
Panel avg: 130d · This submission: 52d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FHQ Holder, Needle, Gastroenterologic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 876.4730
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.