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510(k) K951147

LEIGH MED. TECH. LARYNGOSCOPE BLADE COVER by Leigh Med Tech, Inc. — Product Code CCW

K951147 is an FDA 510(k) premarket notification submitted by Leigh Med Tech, Inc. for the device "LEIGH MED. TECH. LARYNGOSCOPE BLADE COVER". The FDA issued a decision of Substantially Equivalent on June 8, 1995. The device falls under product code CCW (Laryngoscope, Rigid), a Class I device regulated under 21 CFR 868.5540. Leigh Med Tech, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 8, 1995
Date Received
March 13, 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 Leigh Med Tech, Inc.

  • K904658 — AUTOMATED DISPOSABLE SOFT TISSUE BIOPSY ASPIR. DEV (November 20, 1990)

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)
  • K062230 — MR FIBER OPTIC INTUBATING LARYNGOSCOPE HANDLE, SHORT, MODEL 310002 (August 31, 2006)
  • K062231 — MR FIBER OPTIC INTUBATING LARYNGOSCOPE HANDLE, STANDARD, MODEL 310001 (August 31, 2006)
  • K041852 — MR TESTED FIBER OPTIC SHORT LARYNGOSCOPE HANDLE, MODEL 310002 (November 15, 2004)
  • K984101 — FLEXIBLADE (September 3, 1999)

FDA data resources