Cleared Special

K143598 - Lapro-Clip Auto Suture Reusable Long Clip Applier

K143598 is an FDA 510(k) clearance for Lapro-Clip Auto Suture Reusable Long Cl..., manufactured by Covidien, LLC. The device is a Class 2 General & Plastic Surgery device with product code FZP cleared through the Special 510(k) pathway after a 84-day FDA review.

K143598 · Covidien, LLC · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2015
Decision
84d
Days
Class 2
Risk

K143598 is an FDA 510(k) clearance for the Lapro-Clip Auto Suture Reusable Long Clip Applier. Classified as Clip, Implantable (product code FZP), Class II - Special Controls.

Submitted by Covidien, LLC (North Haven, US). The FDA issued a Cleared decision on March 12, 2015 after a review of 84 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, LLC devices

FDA 510(k) Submission Details - K143598

510(k) Number K143598 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 18, 2014
Decision Date March 12, 2015
Days to Decision 84 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
31d faster than avg
Panel avg: 115d · This submission: 84d
Pathway characteristics
Modification to existing cleared device.

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 104
Devices cleared under the same product code (FZP) and FDA review panel - the closest regulatory comparables to K143598.
Ligaclip 10mm M/L Endoscopic Rotating Multiple Clip Applier
K150840 · Ethicon Endo-Surgery, LLC · Sep 2015
Weck Auto Endo5 Hem-o-lok Ligating Clip Applier
K152081 · Teleflexmedical, Inc. · Aug 2015
AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip
K150996 · AtriCure, Inc. · Jun 2015
Weck Hem-o-lok Auto Endo5 Ligating Clip Applier
K142777 · Teleflexmedical, Inc. · Dec 2014
Premium Surgiclip III
K142869 · Covidien · Oct 2014
ATRICLIP LAA EXCLUSION SYSTEM WITH PRELOADED GILLINOV-COSGROVE CLIP
K142120 · AtriCure, Inc. · Aug 2014