Cleared Special

K142869 - Premium Surgiclip III

K142869 is the FDA 510(k) clearance for Premium Surgiclip III by Covidien. It is a Class 2 General & Plastic Surgery device (product code FZP) cleared through the Special 510(k) pathway after a 29-day FDA review.

K142869 · Covidien · General & Plastic Surgery device
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Oct 2014
Decision
29d
Days
Class 2
Risk

K142869 is an FDA 510(k) clearance for the Premium Surgiclip III. Classified as Clip, Implantable (product code FZP), Class II - Special Controls.

Submitted by Covidien (North Haven, US). The FDA issued a Cleared decision on October 30, 2014 after a review of 29 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Covidien devices

Submission Details

510(k) Number K142869 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 01, 2014
Decision Date October 30, 2014
Days to Decision 29 days
Submission Type Special
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
86d faster than avg
Panel avg: 115d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

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 70
Devices cleared under the same product code (FZP) and FDA review panel - the closest regulatory comparables to K142869.
SureClip
K150936 · Conmed Corporation · Oct 2015
Premium Surgiclip¿
K143644 · Covidien · Sep 2015
Lapro-Clip Auto Suture Reusable Long Clip Applier
K143598 · Covidien, LLC · Mar 2015
ENDO CLIP III 5MM CLIP APPLIER
K121194 · Covidien · May 2012
ENDOSCOPIC CLIP SYSTEM
K102081 · Aesculap, Inc. · Aug 2010
U-CLIP UNI-FIRE, MODEL M65
K081082 · Medtronic, Inc. · May 2008