Cleared Traditional

VASOVASOSTOMY SET (K921546) - FDA 510(k) Clearance

Class I Gastroenterology & Urology device.

K921546 · Cook Urological, Inc. · Gastroenterology & Urology device
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Jul 1993
Decision
457d
Days
Class 1
Risk

K921546 is an FDA 510(k) clearance for the VASOVASOSTOMY SET. Classified as Surgical Instruments, G-u, Manual (and Accessories) (product code KOA), Class I - General Controls.

Submitted by Cook Urological, Inc. (Spencer, US). The FDA issued a Cleared decision on July 2, 1993 after a review of 457 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.4730 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Gastroenterology & Urology submissions.

View all Cook Urological, Inc. devices

Submission Details

510(k) Number K921546 FDA.gov
FDA Decision Cleared Substantially Equivalent - Special 510(k) (SESK)
Date Received April 01, 1992
Decision Date July 02, 1993
Days to Decision 457 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
327d slower than avg
Panel avg: 130d · This submission: 457d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KOA Surgical Instruments, G-u, Manual (and Accessories)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 876.4730
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.