Cleared Traditional

MILTEX LIGATING CLIP (K052018) - FDA 510(k) Clearance

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

K052018 · Miltex, Inc. · General & Plastic Surgery device
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Nov 2005
Decision
101d
Days
Class 2
Risk

K052018 is an FDA 510(k) clearance for the MILTEX LIGATING CLIP. Classified as Clip, Implantable (product code FZP), Class II - Special Controls.

Submitted by Miltex, Inc. (York, US). The FDA issued a Cleared decision on November 4, 2005 after a review of 101 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 Miltex, Inc. devices

Submission Details

510(k) Number K052018 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 26, 2005
Decision Date November 04, 2005
Days to Decision 101 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
14d faster than avg
Panel avg: 115d · This submission: 101d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 64
Devices cleared under the same product code (FZP) and FDA review panel - the closest regulatory comparables to K052018.
AUTO SUTURE ENDO CLIP III 5 MM CLIP APPLIER
K061288 · United States Surgical, A Division of Tyco Healthc · 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
IVS CLIP CLOSURE SYSTEM, MODEL 1002 (IVS CLIP APPLIER), 14677
K051125 · Abbott Laboratories · Jun 2005
AUTO SUTURE MICRO SURGICLIP CLIP APPLIER
K001450 · United States Surgical, A Division of Tyco Healthc · Jul 2000
MODIFIED AUTO SUTURE*VCS** ANASTOMOTIC**CLIP CARTRIDGE
K984438 · United States Surgical, A Division of Tyco Healthc · Jan 1999