Cleared Traditional

K973633 - ATRION MEDICAL PRODUCTS LACRIMAL INTUBATION SET (FDA 510(k) Clearance)

K973633 · Atrion Medical Products, Inc. · Ophthalmic device
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Jan 1998
Decision
183d
Days
-
Risk

K973633 is an FDA 510(k) clearance for the ATRION MEDICAL PRODUCTS LACRIMAL INTUBATION SET. Classified as Lacrimal Stents And Intubation Sets (product code OKS).

Submitted by Atrion Medical Products, Inc. (Arab, US). The FDA issued a Cleared decision on January 16, 1998 after a review of 183 days - an extended review 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: 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.

View all Atrion Medical Products, Inc. devices

Submission Details

510(k) Number K973633 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 17, 1997
Decision Date January 16, 1998
Days to Decision 183 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
73d slower than avg
Panel avg: 110d · This submission: 183d
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.