Cleared Traditional

K942068 - AMERICAN CATHETER SPHINCTEROTOME

K942068 is the FDA 510(k) clearance for AMERICAN CATHETER SPHINCTEROTOME by Intl. Medical, Inc.. It is a Class 2 Gastroenterology & Urology device (product code KNS) cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K942068 · Intl. Medical, Inc. · Gastroenterology & Urology device
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Jun 1994
Decision
56d
Days
Class 2
Risk

K942068 is an FDA 510(k) clearance for the AMERICAN CATHETER SPHINCTEROTOME. Classified as Unit, Electrosurgical, Endoscopic (with Or Without Accessories) (product code KNS), Class II - Special Controls.

Submitted by Intl. Medical, Inc. (Fort Myers, US). The FDA issued a Cleared decision on June 24, 1994 after a review of 56 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.4300 - 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 Intl. Medical, Inc. devices

Submission Details

510(k) Number K942068 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 29, 1994
Decision Date June 24, 1994
Days to Decision 56 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
74d faster than avg
Panel avg: 130d · This submission: 56d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KNS Unit, Electrosurgical, Endoscopic (with Or Without Accessories)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.4300
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 - KNS Unit, Electrosurgical, Endoscopic (with Or Without Accessories)

All 95
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