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510(k) K945269

OPTUS LARYNGOSCOPES by Optus, Inc. — Product Code CCW

K945269 is an FDA 510(k) premarket notification submitted by Optus, Inc. for the device "OPTUS LARYNGOSCOPES". The FDA issued a decision of Substantially Equivalent on November 7, 1994. The device falls under product code CCW (Laryngoscope, Rigid), a Class I device regulated under 21 CFR 868.5540. Optus, Inc. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 7, 1994
Date Received
October 28, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Laryngoscope, Rigid
Device Class
Class I
Regulation Number
868.5540
Review Panel
AN
Submission Type

Other clearances by Optus, Inc.

  • K945264 — OPTUS OTOSCOPES (February 2, 1996)
  • K953913 — OPTUS ARTHROSCOPE & MINI-ARTHROSCOPE ACCESSORIES (January 22, 1996)
  • K945268 — OPTUS BRONCHOSCOPES (December 21, 1995)
  • K945265 — OPTUS HYSTEROSCOPES AND CONTACT HYSTEROSCOPES (September 12, 1995)
  • K945262 — OPTUS CYSTOSCOPES AND PEDIATRIC CYSTOSCOPES (May 26, 1995)
  • K945267 — OPTUS ARTHROSCOPES AND MINI-ARTHROSCOPES (May 23, 1995)
  • K945266 — OPTUS LAPAROSCOPES AND OPERATING LAPAROSCOPES (February 23, 1995)
  • K944656 — OPTUS SINUSCOPES AND ACCESSORIES (January 26, 1995)
  • K945263 — OPTUS THORACOSCOPES (December 13, 1994)

Other clearances for product code CCW

  • K191602 — APA Oxy Blade (August 2, 2019)
  • K163412 — Girgis Scope Video 200 Double Bladed Laryngoscope (GSV200.DBL) (June 22, 2017)
  • K140951 — YEESCOPE LARYNGOSCOPES (November 10, 2014)
  • K121378 — AIRTRAQ SP AIRTRAQ AVANT (June 21, 2012)
  • K063477 — NOVAMED MRI CONDITIONAL LARYNGOSCOPE SET (February 9, 2007)
  • K062523 — TRU-MR LARYNGOSCOPE SET (November 17, 2006)
  • K062231 — MR FIBER OPTIC INTUBATING LARYNGOSCOPE HANDLE, STANDARD, MODEL 310001 (August 31, 2006)
  • K062230 — MR FIBER OPTIC INTUBATING LARYNGOSCOPE HANDLE, SHORT, MODEL 310002 (August 31, 2006)
  • K041852 — MR TESTED FIBER OPTIC SHORT LARYNGOSCOPE HANDLE, MODEL 310002 (November 15, 2004)
  • K984101 — FLEXIBLADE (September 3, 1999)

FDA data resources