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510(k) K962151

RYDER LACRIMAL INTUBATIONSET by Ryder Intl. Corp. — Product Code OKS

K962151 is an FDA 510(k) premarket notification submitted by Ryder Intl. Corp. for the device "RYDER LACRIMAL INTUBATIONSET". The FDA issued a decision of Substantially Equivalent on September 18, 1996. The device falls under product code OKS (Lacrimal Stents And Intubation Sets), a Class U device. Ryder Intl. Corp. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 18, 1996
Date Received
June 4, 1996
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 Ryder Intl. Corp.

  • K962611 — BARD EAGLE INFLATION DEVICE (October 21, 1996)
  • K953522 — USCI IDEAL PTCA KIT (April 17, 1996)
  • K920064 — OPTI-LENS CONTACT LENS CASE (March 4, 1992)
  • K915082 — OPTI-LENS(TM) CONTACT LENS CASE (January 13, 1992)
  • K881981 — ASSIST(TM) ASEPTIC SYRINGE IRRIGATION SYSTEM (August 2, 1988)
  • K870278 — CONTACT LENS CASE W/POSTIVE HEAT INDI. MOD. #695 (February 20, 1987)
  • K853727 — KESTREL CONTACT LENS STORAGE CASE(POLYSULFONE) (February 7, 1986)
  • K853728 — KESTREL CONTACT LENS STORAGE CASE(NORYL) (December 13, 1985)
  • K853729 — KESTREL CONTACT LENS STORAGE CASE(POLYSTYRENE) (December 13, 1985)

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