Cleared Traditional

K053255 - NEXUS LIGATING CLIP

K053255 is an FDA 510(k) clearance for NEXUS LIGATING CLIP, manufactured by Microsurgical Laboratories,Inc.Dba Wexler Surgical. The device is a Class 2 General & Plastic Surgery device with product code FZP cleared through the Traditional 510(k) pathway after a 113-day FDA review.

K053255 · Microsurgical Laboratories,Inc.Dba Wexler Surgical · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2006
Decision
113d
Days
Class 2
Risk

K053255 is an FDA 510(k) clearance for the NEXUS LIGATING CLIP. Classified as Clip, Implantable (product code FZP), Class II - Special Controls.

Submitted by Microsurgical Laboratories,Inc.Dba Wexler Surgical (Bellaire, US). The FDA issued a Cleared decision on March 14, 2006 after a review of 113 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Microsurgical Laboratories,Inc.Dba Wexler Surgical devices

FDA 510(k) Submission Details - K053255

510(k) Number K053255 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 21, 2005
Decision Date March 14, 2006
Days to Decision 113 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
2d faster than avg
Panel avg: 115d · This submission: 113d
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 108
Devices cleared under the same product code (FZP) and FDA review panel - the closest regulatory comparables to K053255.
AUTO SUTURE ENDO CLIP III 5 MM CLIP APPLIER
K061288 · United States Surgical, A Division of Tyco Healthc · Nov 2006
HEM-O-LOK LIGATION CLIP
K062914 · Teleflex Medical · Nov 2006
U-CLIP DEVICE, MODEL NC65
K062057 · Medtronic Vascular · Aug 2006
U-CLIP DEVICE, MODELS B140, B160 AND B180
K053252 · Medtronic Vascular · Dec 2005
MILTEX LIGATING CLIP
K052018 · Miltex, Inc. · Nov 2005
IVS CLIP CLOSURE SYSTEM, MODEL 1002 (IVS CLIP APPLIER), 14677
K051125 · Abbott Laboratories · Jun 2005