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510(k) K991238

FCI CRAWFORD PROBE INTUBATION SETS by Fci Ophthalmics, Inc. — Product Code OKS

K991238 is an FDA 510(k) premarket notification submitted by Fci Ophthalmics, Inc. for the device "FCI CRAWFORD PROBE INTUBATION SETS". The FDA issued a decision of Substantially Equivalent on July 8, 1999. The device falls under product code OKS (Lacrimal Stents And Intubation Sets), a Class U device. Fci Ophthalmics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 8, 1999
Date Received
April 12, 1999
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 Fci Ophthalmics, Inc.

  • K061404 — MONO-CRAWFORD NASO-LACRIMAL INTUBATION DEVICE (August 7, 2006)
  • K061398 — SNUG PLUG PUNCTUM PLUG (July 11, 2006)
  • K041869 — SELF RETAINING BICANALICULUS INTUBATION SET (November 18, 2004)
  • K023758 — BECKER TRANSNASAL LACRIMAL (INTUBATION SETS) (September 17, 2003)
  • K023400 — FCI MESH WRAPPED BIOCERAMIC ORBITAL IMPLANT (August 22, 2003)
  • K030054 — DISPOSABLE VITRECTOMY SETS, DISPOSABLE VIRECTOMY LENSES (February 26, 2003)
  • K992294 — BIOCERAMIC ORBITAL IMPLANT (April 19, 2000)
  • K980816 — RETINAL DETACHMENT IMPLANTS, INCLUDING BANDS, STRIPS (RAILS) AND SPONGES (September 18, 1998)
  • K980822 — TITANIUM PEG SYSTEM (July 9, 1998)
  • K964774 — PUNCTUM PLUGS & READY-SET PUNCTAL PLUGS (December 20, 1996)

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