Cleared Traditional

O'NEIL STERILE FIELD INTERMITTENT URINARY CATHETER (K993651) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K993651 · Sc Hennig Enterprises Europe Srl · Gastroenterology & Urology device
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Dec 1999
Decision
55d
Days
Class 2
Risk

K993651 is an FDA 510(k) clearance for the O'NEIL STERILE FIELD INTERMITTENT URINARY CATHETER. Classified as Catheter, Urethral (product code GBM), Class II - Special Controls.

Submitted by Sc Hennig Enterprises Europe Srl (Western Australia, AU). The FDA issued a Cleared decision on December 23, 1999 after a review of 55 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5130 - 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 Sc Hennig Enterprises Europe Srl devices

Submission Details

510(k) Number K993651 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 29, 1999
Decision Date December 23, 1999
Days to Decision 55 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
75d faster than avg
Panel avg: 130d · This submission: 55d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GBM Catheter, Urethral
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5130
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - GBM Catheter, Urethral

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