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510(k) K113118

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

K113118 is an FDA 510(k) premarket notification submitted by Quest Medical, Inc. for the device "STENTUBE LACRIMAL INTUBATION SET". The FDA issued a decision of Substantially Equivalent on July 31, 2012. The device falls under product code OKS (Lacrimal Stents And Intubation Sets), a Class U device. Quest Medical, Inc. has at least 10 other 510(k) clearances on record.

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.

Other clearances by Quest Medical, Inc.

  • K241058 — Lyka® PORT Needle Free Access Device (4170Y) (December 18, 2024)
  • K213846 — Q2 Blood Administration Sets (June 5, 2022)
  • K213588 — Q2 IV Administration Sets (June 2, 2022)
  • K202672 — Precision Delivery Infusion Set (January 21, 2021)
  • K201984 — MPS 3 ND Myocardial Protection System (November 20, 2020)
  • K200438 — MPS 3 Myocardial Protection System (June 19, 2020)
  • K182442 — MiniGuard Arterial Safety Valve (November 6, 2018)
  • K173716 — MPS2 Myocardial Protection System Console (October 1, 2018)
  • 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)

FDA data resources