Cleared Traditional

K140932 - AMSEL OCCLUDER DEVICE

K140932 is the FDA 510(k) clearance for AMSEL OCCLUDER DEVICE by Amsel Medical Corporation. It is a Class 2 General & Plastic Surgery device (product code FZP) cleared through the Traditional 510(k) pathway after a 287-day FDA review.

K140932 · Amsel Medical Corporation · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2015
Decision
287d
Days
Class 2
Risk

K140932 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 Corporation (Providence, US). The FDA issued a Cleared decision on January 23, 2015 after a review of 287 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 Amsel Medical Corporation devices

Submission Details

510(k) Number K140932 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 11, 2014
Decision Date January 23, 2015
Days to Decision 287 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
172d slower than avg
Panel avg: 115d · This submission: 287d
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 97
Devices cleared under the same product code (FZP) and FDA review panel - the closest regulatory comparables to K140932.
Weck Auto Endo5 Hem-o-lok Ligating Clip Applier
K152081 · Teleflexmedical, Inc. · Aug 2015
AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip
K150996 · AtriCure, Inc. · Jun 2015
Lapro-Clip Auto Suture Reusable Long Clip Applier
K143598 · Covidien, LLC · Mar 2015
Weck Hem-o-lok Auto Endo5 Ligating Clip Applier
K142777 · Teleflexmedical, Inc. · Dec 2014
Premium Surgiclip III
K142869 · Covidien · Oct 2014
ATRICLIP LAA EXCLUSION SYSTEM WITH PRELOADED GILLINOV-COSGROVE CLIP
K142120 · AtriCure, Inc. · Aug 2014