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510(k) K041852

MR TESTED FIBER OPTIC SHORT LARYNGOSCOPE HANDLE, MODEL 310002 by Minrad, Inc. — Product Code CCW

K041852 is an FDA 510(k) premarket notification submitted by Minrad, Inc. for the device "MR TESTED FIBER OPTIC SHORT LARYNGOSCOPE HANDLE, MODEL 310002". The FDA issued a decision of Substantially Equivalent on November 15, 2004. The device falls under product code CCW (Laryngoscope, Rigid), a Class I device regulated under 21 CFR 868.5540. Minrad, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 15, 2004
Date Received
July 8, 2004
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 Minrad, Inc.

  • K072255 — MINRAD INC. NASAL SCAVENGING CIRCUIT (October 18, 2007)
  • K071814 — LIGHT SABRE SPINAL ACCESS DEVICE (October 16, 2007)
  • 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)
  • K041846 — SABRESOURCE DRAPE (August 26, 2004)
  • K021084 — LIGHT SABER SPINAL NEEDLE (July 3, 2002)
  • K013040 — LIGHT SABER INTRODUCER NEEDLE (December 7, 2001)
  • K982735 — LIGHT SABER BONE BIOPSY NEEDLE (September 9, 1998)
  • K982018 — LIGHT SABER ASPIRATION NEEDLE (August 7, 1998)
  • K981796 — LIGHT SABER CORE TISSUE NEEDLE (August 5, 1998)

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)
  • K984101 — FLEXIBLADE (September 3, 1999)
  • K971377 — GREATBATCH SCIENTIFIC MR COMPATIBLE LARYNGOSCOPE (April 30, 1998)

FDA data resources