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510(k) K945901

DIRECT VIEW 2001 FIBERLIGHT by Mercury Medical — Product Code CCW

K945901 is an FDA 510(k) premarket notification submitted by Mercury Medical for the device "DIRECT VIEW 2001 FIBERLIGHT". The FDA issued a decision of Substantially Equivalent on Dec 27, 1994. The device falls under product code CCW (Laryngoscope, Rigid), a Class I device regulated under 21 CFR 868.5540. Mercury Medical has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Dec 27, 1994
Date Received
Dec 2, 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 Mercury Medical

  • K142096 — T-PIECE RESUSCITATOR (Oct 17, 2014)
  • K093913 — MERCURY MEDICAL T-PIECE RESUSCITATOR (Apr 6, 2010)
  • K090710 — MERCURY CPAP (Aug 20, 2009)
  • K083056 — NEO-STAT CO2 <KG (Feb 23, 2009)
  • K032593 — MERCURY MEDICAL NEGATIVE INSPIRATORY FORCE (NIF) DISPOSABLE MONOMETER (Feb 3, 2004)
  • K031814 — STATCO2METER, MODEL 10-55372 (Aug 14, 2003)
  • K031411 — MINI STATCO2 CO2 DETECTOR, MODEL 10-55371 (Jul 30, 2003)
  • K021576 — MERCURY MEDICAL STATCO2 END TIDAL CO2 DETECTOR, MODEL 10-55370 (Nov 4, 2002)
  • K001714 — MERCURY MEDICAL HYPERINFLATION BAG SYSTEM, MODEL 83-900-0149 (Nov 3, 2000)
  • K000073 — MERCURY MEDICAL DISPOSABLE RADIOFREQUENCY CANNULA (Mar 1, 2000)

Other clearances for product code CCW

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

FDA data resources