Cleared Traditional

K230966 - angiOCCLUDE Ligating Clips (FDA 510(k) Clearance)

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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
53d slower than avg
Panel avg: 114d · This submission: 167d
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 175
Devices cleared under the same product code (FZP) and FDA review panel - the closest regulatory comparables to K230966.
InnoClip Clip Applier
K253781 · Taiwan Surgical Corporation · Dec 2025
InnoClip Disposable Clip Applier
K253903 · Taiwan Surgical Corporation · Dec 2025
Disposable Polymer Ligation Clips
K250643 · Hangzhou Kangji Medical Instrument Co., Ltd. · Nov 2025
Hem-o-lok™ PurplePlus™ Large Polymer Ligating Clips
K251054 · Teleflex Medical · Jul 2025
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