Cleared Traditional

K230966 - angiOCCLUDE Ligating Clips

K230966 is an FDA 510(k) clearance for angiOCCLUDE Ligating Clips, manufactured by A2 Medical Systems, LLC. The device is a Class 2 General & Plastic Surgery device with product code FZP cleared through the Traditional 510(k) pathway after a 167-day FDA review.

K230966 · A2 Medical Systems, LLC · General & Plastic Surgery device
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Sep 2023
Decision
167d
Days
Class 2
Risk

K230966 is an FDA 510(k) clearance for the angiOCCLUDE Ligating Clips. Classified as Clip, Implantable (product code FZP), Class II - Special Controls.

Submitted by A2 Medical Systems, LLC (Kalamazoo, US). The FDA issued a Cleared decision on September 19, 2023 after a review of 167 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 A2 Medical Systems, LLC devices

FDA 510(k) Submission Details - K230966

510(k) Number K230966 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 05, 2023
Decision Date September 19, 2023
Days to Decision 167 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
52d slower than avg
Panel avg: 115d · This submission: 167d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K230966.
GEM ZIPCLIP
K242541 · Synovis Micro Companies Alliance A Subsidiary of Baxter Int · Jan 2025
SOLID CLIP™ Single Use Clip Applier
K221495 · Medscope Biotech Co., Ltd. · Jul 2024
Hem-o-lok® Ligating Clips
K232970 · Teleflex Medical · Jan 2024
LIGACLIP Endoscopic Rotating Multiple Clip Applier 12mm L (ER420)
K232313 · Ethicon Endo-Surgery, LLC · Aug 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