510(k) K113118

STENTUBE LACRIMAL INTUBATION SET by Quest Medical, Inc. — Product Code OKS

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: July 31, 2012
Date Received: October 21, 2011
Clearance Type: Special
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Lacrimal Stents And Intubation Sets
Device Class: Class U
Regulation Number
Review Panel: OP
Submission Type

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.

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K162804 — Q2 Low Pressure Power Injection Extension Set (March 8, 2017)
K162304 — Q2 Multiport IV Administration Sets and Extension Sets, Checkmate Multiport IV A (December 6, 2016)

Other clearances for product code OKS

K201892 — Ritleng®+ and Ritleng®+ PVP (March 11, 2021)
K201606 — LacriJet® (December 18, 2020)
K170247 — Lacriflow CL (April 18, 2017)
K161373 — Nunchaku (November 3, 2016)
K160710 — Oasis Lacrimal Intubation Set (May 13, 2016)
K142914 — DacryoCATH (January 12, 2015)
K140290 — STOPLOSS JONES TUBE (December 2, 2014)
K130375 — SELF-RETAINING BICANALICULUS INTUBATON SET II (December 4, 2013)
K123831 — OPHTACATH KIT (July 29, 2013)
K120886 — LACRIFAST (December 17, 2012)