Cleared Traditional

TI CLIP APPLIER (K034029) - FDA 510(k) Clearance

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

K034029 · Gyrx, LLC · General & Plastic Surgery device
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Mar 2004
Decision
67d
Days
Class 2
Risk

K034029 is an FDA 510(k) clearance for the TI CLIP APPLIER. Classified as Clip, Vas Deferens (product code NJC), Class II - Special Controls.

Submitted by Gyrx, LLC (Jacksonville, US). The FDA issued a Cleared decision on March 5, 2004 after a review of 67 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 Gyrx, LLC devices

Submission Details

510(k) Number K034029 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 29, 2003
Decision Date March 05, 2004
Days to Decision 67 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
48d faster than avg
Panel avg: 115d · This submission: 67d
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.