Cleared Traditional

ENDOSERTER (K090626) - FDA 510(k) Clearance

Class I Ophthalmic device.

K090626 · Ocular Systems, Inc. · Ophthalmic device
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Jan 2011
Decision
683d
Days
Class 1
Risk

K090626 is an FDA 510(k) clearance for the ENDOSERTER. Classified as Graft Insertion Instrument For Endothelial Keratoplasty (product code OTZ), Class I - General Controls.

Submitted by Ocular Systems, Inc. (Winston-Salem, US). The FDA issued a Cleared decision on January 21, 2011 after a review of 683 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Ophthalmic submissions.

View all Ocular Systems, Inc. devices

Submission Details

510(k) Number K090626 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 09, 2009
Decision Date January 21, 2011
Days to Decision 683 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
573d slower than avg
Panel avg: 110d · This submission: 683d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code OTZ Graft Insertion Instrument For Endothelial Keratoplasty
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.4300
Definition A Graft Insertion Device For Endothelial Keratoplasty Is A Device Intended To Be Inserted Into The Eye During Surgery To Direct The Insertion Of A Corneal Graft And Be Removed After Insertion Is Completed.
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.