Cleared Special

K232313 - LIGACLIP Endoscopic Rotating Multiple C...

Also marketed or referenced as:
LIGACLIP Endoscopic Rotating Multiple Clip Applier 10mm M/L (ER320)

K232313 is the FDA 510(k) clearance for LIGACLIP Endoscopic Rotating Multiple C... by Ethicon Endo-Surgery, LLC. It is a Class 2 General & Plastic Surgery device (product code FZP) cleared through the Special 510(k) pathway after a 27-day FDA review.

K232313 · Ethicon Endo-Surgery, LLC · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2023
Decision
27d
Days
Class 2
Risk

K232313 is an FDA 510(k) clearance for the LIGACLIP Endoscopic Rotating Multiple Clip Applier 12mm L (ER420). Classified as Clip, Implantable (product code FZP), Class II - Special Controls.

Submitted by Ethicon Endo-Surgery, LLC (Guaynabo, PR). The FDA issued a Cleared decision on August 29, 2023 after a review of 27 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 Ethicon Endo-Surgery, LLC devices

Submission Details

510(k) Number K232313 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 02, 2023
Decision Date August 29, 2023
Days to Decision 27 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
88d faster than avg
Panel avg: 115d · This submission: 27d
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 96
Devices cleared under the same product code (FZP) and FDA review panel - the closest regulatory comparables to K232313.
SOLID CLIP™ Single Use Clip Applier
K221495 · Medscope Biotech Co., Ltd. · Jul 2024
Hem-o-lok® Ligating Clips
K232970 · Teleflex Medical · Jan 2024
angiOCCLUDE Ligating Clips
K230966 · A2 Medical Systems, LLC · Sep 2023
Weck Auto Endo5 5mm Automatic Endoscopic 35cm Applier (AE05ML)
K230480 · Teleflex Medical · Apr 2023
DuraFuse Clip and Applier System
K213813 · Neuramedica, Inc. · Jul 2022
angioLOCK Polymer Ligating Clip
K220006 · A2 Medical Systems, LLC · Mar 2022