Cleared Traditional

GEUDER INJECTOR FOR MORCHER CAPSULAR TENSION RING (K001125) - FDA 510(k) Clearance

Class I Ophthalmic device.

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

K001125 is an FDA 510(k) clearance for the GEUDER INJECTOR FOR MORCHER CAPSULAR TENSION RING. Classified as Injector, Capsular Tension Ring (product code NCE), Class I - General Controls.

Submitted by Geuder GmbH (Centercille, US). The FDA issued a Cleared decision on October 4, 2000 after a review of 180 days - an extended review cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4300 - the FDA ophthalmic 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 Ophthalmic review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K001125 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
70d slower than avg
Panel avg: 110d · This submission: 180d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code NCE Injector, Capsular Tension Ring
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.4300
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.