Cleared Traditional

K180650 - Amsel Endo Occluder (FDA 510(k) Clearance)

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

K180650 · Amsel Medical Corporation · General & Plastic Surgery device
Nov 2018
Decision
247d
Days
Class 2
Risk

K180650 is an FDA 510(k) clearance for the Amsel Endo Occluder. Classified as Clip, Implantable (product code FZP), Class II - Special Controls.

Submitted by Amsel Medical Corporation (Cambridge, US). The FDA issued a Cleared decision on November 15, 2018 after a review of 247 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.

Submission Details

510(k) Number K180650 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 13, 2018
Decision Date November 15, 2018
Days to Decision 247 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
115d slower than avg
Panel avg: 132d · This submission: 247d
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 7
Devices cleared under the same product code (FZP) and FDA review panel - the closest regulatory comparables to K180650.
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
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