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510(k) K973633

ATRION MEDICAL PRODUCTS LACRIMAL INTUBATION SET by Atrion Medical Products, Inc. — Product Code OKS

K973633 is an FDA 510(k) premarket notification submitted by Atrion Medical Products, Inc. for the device "ATRION MEDICAL PRODUCTS LACRIMAL INTUBATION SET". The FDA issued a decision of Substantially Equivalent on January 16, 1998. The device falls under product code OKS (Lacrimal Stents And Intubation Sets), a Class U device. Atrion Medical Products, Inc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 16, 1998
Date Received
July 17, 1997
Clearance Type
Traditional
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 Atrion Medical Products, Inc.

  • K060643 — QL LOCKING SYRINGE (July 12, 2006)
  • K043249 — ATRION NEEDLEVISE LARGE-BORE SHARPS SECURING DEVICE (May 25, 2005)
  • K041158 — ATRION EPIDURAL ANESTHESIA KIT WITH ATRION NEEDLEVISE SHARPS SECURING SYSTEM (June 16, 2004)
  • K032840 — ATRION MEDICAL QL INFLATION DEVICE (March 3, 2004)
  • K020333 — ATRION MEDICAL QL FLUID DISPENSING SYRINGE (April 25, 2002)
  • K973872 — ATRION MEDICAL COATED LACRIMAL INTUBATION SET (January 8, 1998)
  • K972964 — ATRION MEDICAL BALLOON CATHETER INFLATION DEVICE (October 10, 1997)
  • K971100 — ATRION MEDICAL AUTOGENOUS TISSUE COLLECTOR (May 23, 1997)

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