Cleared Traditional

TEMPORARY INTRACANALICULAR COLLAGEN IMPLANT (K890919) - FDA 510(k) Clearance

K890919 · Eagle Vision, Inc. · Ophthalmic device
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May 1989
Decision
82d
Days
-
Risk

K890919 is an FDA 510(k) clearance for the TEMPORARY INTRACANALICULAR COLLAGEN IMPLANT. Classified as Plug, Punctum (product code LZU).

Submitted by Eagle Vision, Inc. (Bethesda, US). The FDA issued a Cleared decision on May 16, 1989 after a review of 82 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Eagle Vision, Inc. devices

Submission Details

510(k) Number K890919 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 23, 1989
Decision Date May 16, 1989
Days to Decision 82 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
28d faster than avg
Panel avg: 110d · This submission: 82d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LZU Plug, Punctum
Device Class -