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510(k) K970619

GREATBATCH SCIENTIFIC MRI COMPATIBLE FIBER OPTIC LARYNGOSCOPE HANDLE by Wilson Greatbatch Technologies, Inc. — Product Code CCW

K970619 is an FDA 510(k) premarket notification submitted by Wilson Greatbatch Technologies, Inc. for the device "GREATBATCH SCIENTIFIC MRI COMPATIBLE FIBER OPTIC LARYNGOSCOPE HANDLE". The FDA issued a decision of Substantially Equivalent on November 19, 1997. The device falls under product code CCW (Laryngoscope, Rigid), a Class I device regulated under 21 CFR 868.5540. Wilson Greatbatch Technologies, Inc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 19, 1997
Date Received
February 18, 1997
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 Wilson Greatbatch Technologies, Inc.

  • K971374 — GREATBATCH SCIENTIFIC MR COMPATIBLE HYSTEROSCOPE (May 13, 1998)
  • K971377 — GREATBATCH SCIENTIFIC MR COMPATIBLE LARYNGOSCOPE (April 30, 1998)
  • K972280 — GREATBATCH SCIENTIFIC MR COMPATIBLE LAPAROSCOPES AND OPERATING LAPAROSCOPES (December 11, 1997)
  • K971781 — GREATBATCH SCIENTIFIC MR COMPATIBLE ARTHROSCOPES AND SMALL JOINT ARTHROSCOPES (November 21, 1997)
  • K971375 — GREATBATCH SCIENTIFIC MR COMPATIBLE SINUSCOPE (October 31, 1997)
  • K954649 — WGL ENDOSCOPIC GRASPER W/DETACHABLE STRAP (December 22, 1995)
  • K950063 — WGL ENDOSCOPIC GRASPER* (January 27, 1995)
  • K942168 — WGL ENDOSCOPIC GRASPER (December 13, 1994)

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