Cleared Traditional

EV MONOCANALICULAR STENT (TM) (K883233) - FDA 510(k) Clearance

K883233 · Eagle Vision, Inc. · Ophthalmic device
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Aug 1988
Decision
21d
Days
-
Risk

K883233 is an FDA 510(k) clearance for the EV MONOCANALICULAR STENT (TM). Classified as Lacrimal Stents And Intubation Sets (product code OKS).

Submitted by Eagle Vision, Inc. (Bethesda, US). The FDA issued a Cleared decision on August 22, 1988 after a review of 21 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 K883233 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 01, 1988
Decision Date August 22, 1988
Days to Decision 21 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
89d faster than avg
Panel avg: 110d · This submission: 21d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code OKS Lacrimal Stents And Intubation Sets
Device Class -
Definition Lacrimal Stents And Intubations Sets Are Intended To Repair The Lacrimal Drainage System. Lacrimal Stents And Intubations Sets Are Indicated For, But Limited To, The Treatment Of Epiphora In Infants And Adults; Canalicular Pathologies Such As Stenosis; Obstruction Or Laceration; And Conditions Requiring Dacryocystorhinostomy (conventional Or Laser); Or Imperforation Of The Nasolacrimal Duct In An Infant.