Cleared Special

K172479 - Amsel Occluder Device

K172479 is an FDA 510(k) clearance for Amsel Occluder Device, manufactured by Amsel Medical. The device is a Class 2 General & Plastic Surgery device with product code FZP cleared through the Special 510(k) pathway after a 29-day FDA review.

K172479 · Amsel Medical · General & Plastic Surgery device
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Sep 2017
Decision
29d
Days
Class 2
Risk

K172479 is an FDA 510(k) clearance for the Amsel Occluder Device. Classified as Clip, Implantable (product code FZP), Class II - Special Controls.

Submitted by Amsel Medical (Cambridge, US). The FDA issued a Cleared decision on September 14, 2017 after a review of 29 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 Amsel Medical devices

FDA 510(k) Submission Details - K172479

510(k) Number K172479 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 16, 2017
Decision Date September 14, 2017
Days to Decision 29 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
86d faster than avg
Panel avg: 115d · This submission: 29d
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 105
Devices cleared under the same product code (FZP) and FDA review panel - the closest regulatory comparables to K172479.
AtriClip FLEX-V
K180010 · AtriCure, Inc. · Jan 2018
AtriClip LAA Exclusion System with Preloaded PRO·V Clip
K173031 · AtriCure, Inc. · Oct 2017
AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (PRO2)
K172742 · AtriCure, Inc. · Oct 2017
AtriClip PRO, PRO2, and PRO V LAA Exclusion System devices with preloaded Gillinov-Cosgrove Clip
K163261 · AtriCure, Inc. · May 2017
Weck Auto Endo10 Automatic Endoscopic Clip Applier
K161758 · Teleflex Medical · Sep 2016
AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip
K160454 · AtriCure, Inc. · Mar 2016