Cleared Traditional

VASCLIP (K021745) - FDA 510(k) Clearance

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K021745 · Vmbc, LLC · General & Plastic Surgery device
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Aug 2002
Decision
84d
Days
Class 2
Risk

K021745 is an FDA 510(k) clearance for the VASCLIP. Classified as Clip, Vas Deferens (product code NJC), Class II - Special Controls.

Submitted by Vmbc, LLC (White Bear Lake, US). The FDA issued a Cleared decision on August 20, 2002 after a review of 84 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4300 - the FDA general and plastic surgery 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 Vmbc, LLC devices

Submission Details

510(k) Number K021745 FDA.gov
FDA Decision Cleared Substantially Equivalent - Abbreviated 510(k) (SESU)
Date Received May 28, 2002
Decision Date August 20, 2002
Days to Decision 84 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
31d faster than avg
Panel avg: 115d · This submission: 84d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NJC Clip, Vas Deferens
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4300
Definition This Is An Implantable Clip Intended To Ligate The Vas Deferens. This Is More Specific Than The Regulation.
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 General & Plastic Surgery devices follow this clearance model.