Cleared Traditional

K921838 - ACUCISE URETERAL CUTTING CATHETER

K921838 is an FDA 510(k) clearance for ACUCISE URETERAL CUTTING CATHETER, manufactured by Applied Urology, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code EYB cleared through the Traditional 510(k) pathway after a 315-day FDA review.

K921838 · Applied Urology, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1993
Decision
315d
Days
Class 2
Risk

K921838 is an FDA 510(k) clearance for the ACUCISE URETERAL CUTTING CATHETER. Classified as Catheter, Ureteral, Gastro-urology (product code EYB), Class II - Special Controls.

Submitted by Applied Urology, Inc. (Launa Hills, US). The FDA issued a Cleared decision on February 26, 1993 after a review of 315 days - an unusually long review period, suggesting complex equivalence evaluation.

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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Applied Urology, Inc. devices

FDA 510(k) Submission Details - K921838

510(k) Number K921838 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 17, 1992
Decision Date February 26, 1993
Days to Decision 315 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
185d slower than avg
Panel avg: 130d · This submission: 315d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EYB Device Classification - Class 2, Special Controls

Product Code EYB Catheter, Ureteral, Gastro-urology
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.