Cleared Traditional

K911109 - OPHTA SIL (R), LACHRYMAL INTUBATION SETS (FDA 510(k) Clearance)

K911109 · G.W.B. Intl., Ltd. · Ophthalmic device
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May 1991
Decision
58d
Days
-
Risk

K911109 is an FDA 510(k) clearance for the OPHTA SIL (R), LACHRYMAL INTUBATION SETS. 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 1, 1991 after a review of 58 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 K911109 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 04, 1991
Decision Date May 01, 1991
Days to Decision 58 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
52d faster than avg
Panel avg: 110d · This submission: 58d
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.