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510(k) K954438

SUNMED'S GREENLINE FIBER OPTIC LARYNGOSCOPE by Rms Div. — Product Code CCW

K954438 is an FDA 510(k) premarket notification submitted by Rms Div. for the device "SUNMED'S GREENLINE FIBER OPTIC LARYNGOSCOPE". The FDA issued a decision of Substantially Equivalent on December 29, 1995. The device falls under product code CCW (Laryngoscope, Rigid), a Class I device regulated under 21 CFR 868.5540. Rms Div. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 29, 1995
Date Received
September 25, 1995
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 Rms Div.

  • K963367 — RMS K-WIRE (October 30, 1996)
  • K944848 — THE VIVACARE T.P.S. PROBE (December 14, 1994)
  • K944557 — DW250 #91 (November 3, 1994)
  • K941625 — DW234 #29 (June 22, 1994)
  • K902403 — ELITE R/F SPOT FILM DRIVE (August 1, 1990)
  • K902146 — SFD-035 SPOT FILM DEVICE (May 31, 1990)
  • K896665 — EXT-600 TABLE, RADIOGRAPHIC, ELEVATING (January 22, 1990)
  • K896119 — RMS 90/15 RADIOGRAPHIC/FLUOROSCOPIC TILTING TABLE (November 27, 1989)
  • K896324 — ELITE 1500 RADIOGRAPHIC TILTING TABLE (November 21, 1989)

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