Cleared Special

STENTUBE LACRIMAL INTUBATION SET (K113118) - FDA 510(k) Clearance

K113118 · Quest Medical, Inc. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2012
Decision
284d
Days
-
Risk

K113118 is an FDA 510(k) clearance for the STENTUBE LACRIMAL INTUBATION SET. Classified as Lacrimal Stents And Intubation Sets (product code OKS).

Submitted by Quest Medical, Inc. (Allen, US). The FDA issued a Cleared decision on July 31, 2012 after a review of 284 days - an extended review cycle.

This device falls under the Ophthalmic FDA review panel. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Quest Medical, Inc. devices

Submission Details

510(k) Number K113118 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 21, 2011
Decision Date July 31, 2012
Days to Decision 284 days
Submission Type Special
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
174d slower than avg
Panel avg: 110d · This submission: 284d
Pathway characteristics
Modification to existing cleared device.

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.