Cleared Traditional

LI VASECTOMY (K932465) - FDA 510(k) Clearance

Class I Gastroenterology & Urology device.

K932465 · Femcare , Ltd. · Gastroenterology & Urology device
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Optimized for regulatory review, auditing and printing
Mar 1994
Decision
285d
Days
Class 1
Risk

K932465 is an FDA 510(k) clearance for the LI VASECTOMY. Classified as Surgical Instruments, G-u, Manual (and Accessories) (product code KOA), Class I - General Controls.

Submitted by Femcare , Ltd. (Ng7 3en England, GB). The FDA issued a Cleared decision on March 2, 1994 after a review of 285 days - an extended review cycle.

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: Standard predicate-based submission. Standard predicate reliance. 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 Femcare , Ltd. devices

Submission Details

510(k) Number K932465 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 21, 1993
Decision Date March 02, 1994
Days to Decision 285 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
155d slower than avg
Panel avg: 130d · This submission: 285d
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.