Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Amsel Endo Occluder

K-Number: K180650 · 2018-11-15

ApplicantAmsel Medical Corporation
Decision Date2018-11-15
Product CodeFZP
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Amsel Endo Occluder is a medical device manufactured by Amsel Medical Corporation. It received FDA 510(k) clearance on 2018-11-15 under approval number K180650. The device is classified under product code FZP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Amsel Endo Occluder?

Amsel Endo Occluder is a medical device that received FDA 510(k) clearance on 2018-11-15. It is manufactured by Amsel Medical Corporation. The 510(k) number is K180650.

When was Amsel Endo Occluder approved by the FDA?

Amsel Endo Occluder received FDA 510(k) clearance on 2018-11-15, under approval number K180650.

What company makes Amsel Endo Occluder?

Amsel Endo Occluder is manufactured by Amsel Medical Corporation.

What is the FDA product code for Amsel Endo Occluder?

The FDA product code for Amsel Endo Occluder is FZP.

Related Devices (Code: FZP)

K161758Weck Auto Endo10 Automatic Endoscopic Clip ApplierTeleflex Medical K151943Vas-Q-ClipNanova Biomaterials, Inc. K160454AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove ClipAtriCure, Inc. K152082Vesocclude Polymer Ligating ClipVesocclude Medical, LLC K153500AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove PRO V ClipAtriCure, Inc. K173031AtriClip LAA Exclusion System with Preloaded PRO·V ClipAtriCure, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑