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510(k) K121378

AIRTRAQ SP AIRTRAQ AVANT by Prodol Meditec , Ltd. — Product Code CCW

K121378 is an FDA 510(k) premarket notification submitted by Prodol Meditec , Ltd. for the device "AIRTRAQ SP AIRTRAQ AVANT". The FDA issued a decision of Substantially Equivalent on June 21, 2012. The device falls under product code CCW (Laryngoscope, Rigid), a Class I device regulated under 21 CFR 868.5540.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 21, 2012
Date Received
May 8, 2012
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

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  • K163412 — Girgis Scope Video 200 Double Bladed Laryngoscope (GSV200.DBL) (June 22, 2017)
  • K140951 — YEESCOPE LARYNGOSCOPES (November 10, 2014)
  • 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)
  • K971377 — GREATBATCH SCIENTIFIC MR COMPATIBLE LARYNGOSCOPE (April 30, 1998)

FDA data resources