Cleared Traditional

K033161 - VISU-LOCK 5MM CLIP APPLIER

K033161 is an FDA 510(k) clearance for VISU-LOCK 5MM CLIP APPLIER, manufactured by Gyrx, LLC. The device is a Class 2 General & Plastic Surgery device with product code FZP cleared through the Traditional 510(k) pathway after a 79-day FDA review.

K033161 · Gyrx, LLC · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2003
Decision
79d
Days
Class 2
Risk

K033161 is an FDA 510(k) clearance for the VISU-LOCK 5MM CLIP APPLIER. Classified as Clip, Implantable (product code FZP), Class II - Special Controls.

Submitted by Gyrx, LLC (Jacksonville, US). The FDA issued a Cleared decision on December 18, 2003 after a review of 79 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.

FDA 510(k) Submission Details - K033161

510(k) Number K033161 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2003
Decision Date December 18, 2003
Days to Decision 79 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
36d faster than avg
Panel avg: 115d · This submission: 79d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FZP Device Classification - Class 2, Special Controls

Product Code FZP Clip, Implantable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4300
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.

Regulatory Peers - FZP Clip, Implantable

All 176
Devices cleared under the same product code (FZP) and FDA review panel - the closest regulatory comparables to K033161.
CORLINK AUTOMATED ANASTOMOTIC SYSTEM
K033979 · By-Pass Makafim , Ltd. · Mar 2004
ANSON REFIX VASCULAR AND TISSUE CLIP, MODELS GF-04-01 AND GF-04-02
K032896 · Anson Medical , Ltd. · Mar 2004
AMI REPROCESSED MULTIPLE CLIP APPLIERS
K032980 · Vanguard Medical Concepts, Inc. · Dec 2003
MODIFICATION TO SUTURE CLINCH
K033024 · Applied Medical Resources Corp. · Oct 2003
TWISTER SUPERELASTIC LIGATING CLIP AND APPLIER
K032238 · Neurosel (Medical) Limited · Sep 2003
14G CORMARK BIOPSY SITE IDENTIFIER
K032217 · Artemis Medical, Inc. · Aug 2003
K033161 · VISU-LOCK 5MM CLIP APPLIER
Download PDF FDA Summary Gyrx, LLC