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510(k) K063477

NOVAMED MRI CONDITIONAL LARYNGOSCOPE SET by Novamed, LLC — Product Code CCW

K063477 is an FDA 510(k) premarket notification submitted by Novamed, LLC for the device "NOVAMED MRI CONDITIONAL LARYNGOSCOPE SET". The FDA issued a decision of Substantially Equivalent on February 9, 2007. The device falls under product code CCW (Laryngoscope, Rigid), a Class I device regulated under 21 CFR 868.5540. Novamed, LLC has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 9, 2007
Date Received
November 16, 2006
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 Novamed, LLC

  • K062020 — LIFESOUND ESOPHAGEAL STETHOSCOPE (September 5, 2006)
  • K000718 — CHROMOSTREAK (August 24, 2000)
  • K974428 — DIPSTREAK (July 30, 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)
  • 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)
  • K971377 — GREATBATCH SCIENTIFIC MR COMPATIBLE LARYNGOSCOPE (April 30, 1998)

FDA data resources