Cleared Traditional

GEUDER INJECTOR FOR MORCHER CAPSULAR TENSION RING

K001125 · Geuder GmbH · Ophthalmic
Oct 2000
Decision
180d
Days
Class 1
Risk

About This 510(k) Submission

K001125 is an FDA 510(k) clearance for the GEUDER INJECTOR FOR MORCHER CAPSULAR TENSION RING, a Injector, Capsular Tension Ring (Class I — General Controls, product code NCE), submitted by Geuder GmbH (Centercille, US). The FDA issued a Cleared decision on October 4, 2000, 180 days after receiving the submission on April 7, 2000. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4300.

Submission Details

510(k) Number K001125 FDA.gov
FDA Decision Cleared SESE
Date Received April 07, 2000
Decision Date October 04, 2000
Days to Decision 180 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement

Device Classification

Product Code NCE — Injector, Capsular Tension Ring
Device Class Class I — General Controls
CFR Regulation 21 CFR 886.4300