Cleared Traditional

K883763 - ACME GUIDEWIRES FOR PERCUTANEOUS INSERT...

K883763 is the FDA 510(k) clearance for ACME GUIDEWIRES FOR PERCUTANEOUS INSERT... by Acme-Monaco Corp.. It is a Class 2 Gastroenterology & Urology device (product code KOD) cleared through the Traditional 510(k) pathway after a 73-day FDA review.

K883763 · Acme-Monaco Corp. · Gastroenterology & Urology device
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Nov 1988
Decision
73d
Days
Class 2
Risk

K883763 is an FDA 510(k) clearance for the ACME GUIDEWIRES FOR PERCUTANEOUS INSERTION OF CATH. Classified as Catheter, Urological (product code KOD), Class II - Special Controls.

Submitted by Acme-Monaco Corp. (Plainville, US). The FDA issued a Cleared decision on November 18, 1988 after a review of 73 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 Acme-Monaco Corp. devices

Submission Details

510(k) Number K883763 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 06, 1988
Decision Date November 18, 1988
Days to Decision 73 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
57d faster than avg
Panel avg: 130d · This submission: 73d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KOD Catheter, Urological
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 - KOD Catheter, Urological

All 106
Devices cleared under the same product code (KOD) and FDA review panel - the closest regulatory comparables to K883763.
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K874112 · Van-Tec, Inc. · Feb 1988