Cleared Special

K121194 - ENDO CLIP III 5MM CLIP APPLIER

K121194 is an FDA 510(k) clearance for ENDO CLIP III 5MM CLIP APPLIER, manufactured by Covidien. The device is a Class 2 General & Plastic Surgery device with product code FZP cleared through the Special 510(k) pathway after a 14-day FDA review.

K121194 · Covidien · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2012
Decision
14d
Days
Class 2
Risk

K121194 is an FDA 510(k) clearance for the ENDO CLIP III 5MM CLIP APPLIER. Classified as Clip, Implantable (product code FZP), Class II - Special Controls.

Submitted by Covidien (North Haven, US). The FDA issued a Cleared decision on May 3, 2012 after a review of 14 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.

FDA 510(k) Submission Details - K121194

510(k) Number K121194 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 19, 2012
Decision Date May 03, 2012
Days to Decision 14 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
101d faster than avg
Panel avg: 115d · This submission: 14d
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 176
Devices cleared under the same product code (FZP) and FDA review panel - the closest regulatory comparables to K121194.
HEMOCLIP TRADITIONAL LIGATING CLIPS, HEMOCLIP PLUS LIGATING CLIPS, HORIZON LIGTING CLIPS
K132658 · Teleflex Medical · Nov 2013
ATRICLIP GILLINOV-COSGROVE LAA CLIP
K131107 · AtriCure, Inc. · May 2013
ATRICLIP LAA EXCLUSION SYSTEM WITH PRELOADED GILLINOV-COSGROVE CLIP
K122276 · AtriCure, Inc. · Aug 2012
ACKERMANN EUROPCLIP
K111930 · Ackermann Instrumente GmbH · Nov 2011
LIGAMAX 5
K110699 · Ethicon Endo-Sugery, LLC · Mar 2011
COLONRING
K093661 · Niti Surgical Solutions, Ltd. · Feb 2011
K121194 · ENDO CLIP III 5MM CLIP APPLIER
Download PDF FDA Summary Covidien