Cleared Special

MODIFICATION TO: LOFRIC PLUS SINGLE USE URINARY CATHETER (K012374) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K012374 · Astra Tech, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
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Aug 2001
Decision
28d
Days
Class 2
Risk

K012374 is an FDA 510(k) clearance for the MODIFICATION TO: LOFRIC PLUS SINGLE USE URINARY CATHETER. Classified as Catheter, Urethral (product code GBM), Class II - Special Controls.

Submitted by Astra Tech, Inc. (Northborough, US). The FDA issued a Cleared decision on August 23, 2001 after a review of 28 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Astra Tech, Inc. devices

Submission Details

510(k) Number K012374 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 26, 2001
Decision Date August 23, 2001
Days to Decision 28 days
Submission Type Special
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
102d faster than avg
Panel avg: 130d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

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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