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Micro-Coil 100 Coil Dialyzer

by Erika, Inc. 510(k)

Active United States

510(k) K800723

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK800723 Date14 May 1980ClearedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 6 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
FHS
Device Class
Class II
Regulation
21 CFR Part 876.5820
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 23 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Micro-Coil 100 Coil Dialyzer is a single coil dialyzer used for the process of dialysis. It functions as a medical device designed to facilitate the filtration of blood.

This device is classified as a Class II medical device under regulation number 876.5820. It has received FDA 510(k) clearance under K800723.

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