Cleared Traditional

K940508 - OPHTA SIL (RITLENG PROBE AND LACRIMAL INTUBATION SET) (FDA 510(k) Clearance)

K940508 · G.W.B. Intl., Ltd. · Ophthalmic device
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May 1994
Decision
89d
Days
-
Risk

K940508 is an FDA 510(k) clearance for the OPHTA SIL (RITLENG PROBE AND LACRIMAL INTUBATION SET). Classified as Lacrimal Stents And Intubation Sets (product code OKS).

Submitted by G.W.B. Intl., Ltd. (Sudbury, US). The FDA issued a Cleared decision on May 4, 1994 after a review of 89 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.

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Submission Details

510(k) Number K940508 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 04, 1994
Decision Date May 04, 1994
Days to Decision 89 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
21d faster than avg
Panel avg: 110d · This submission: 89d
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.