Cleared Traditional

K143644 - Premium Surgiclip¿

Also marketed or referenced as:
Endo Clip¿ AcuClip¿

K143644 is the FDA 510(k) clearance for Premium Surgiclip¿ by Covidien. It is a Class 2 General & Plastic Surgery device (product code FZP) cleared through the Traditional 510(k) pathway after a 266-day FDA review.

K143644 · Covidien · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2015
Decision
266d
Days
Class 2
Risk

K143644 is an FDA 510(k) clearance for the Premium Surgiclip¿. Classified as Clip, Implantable (product code FZP), Class II - Special Controls.

Submitted by Covidien (North Haven, US). The FDA issued a Cleared decision on September 14, 2015 after a review of 266 days - an extended review 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: 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 Covidien devices

Submission Details

510(k) Number K143644 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 22, 2014
Decision Date September 14, 2015
Days to Decision 266 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
151d slower than avg
Panel avg: 115d · This submission: 266d
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 70
Devices cleared under the same product code (FZP) and FDA review panel - the closest regulatory comparables to K143644.
AnastoClip GC Closure System
K173323 · LeMaitre Vascular, Inc. · Mar 2018
AtriClip FLEX-V
K180010 · AtriCure, Inc. · Jan 2018
SureClip
K150936 · Conmed Corporation · Oct 2015
Lapro-Clip Auto Suture Reusable Long Clip Applier
K143598 · Covidien, LLC · Mar 2015
Premium Surgiclip III
K142869 · Covidien · Oct 2014
ENDO CLIP III 5MM CLIP APPLIER
K121194 · Covidien · May 2012