510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K970619Substantially Equivalent

Greatbatch Scientific MRI Compatible Fiber Optic Laryngoscope Handle

Wilson Greatbatch Technologies, Inc., Clarence NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K970619 is the FDA 510(k) clearance record for GREATBATCH SCIENTIFIC MRI COMPATIBLE FIBER OPTIC LARYNGOSCOPE HANDLE, a class I device, cleared for Wilson Greatbatch Technologies, Inc. on under FDA product code CCW (Laryngoscope, Rigid). FDA records list 9 510(k) clearances for Wilson Greatbatch Technologies, Inc., from to . As of , FDA records show no recalls naming K970619.

Clearance record

Decision date
Received
(274 days to decision)
Product code
CCW Laryngoscope, Rigid
Regulation
21 CFR 868.5540
Device class
Class I
Review panel
Anesthesiology
Applicant
Wilson Greatbatch Technologies, Inc. 4100 Barton Rd., Clarence NY
510(k) summary
Summary
Third party review
No

Clearances, product code CCW

Trailing 12 months

FDA records hold no clearances under product code CCW in the trailing twelve months.

FDA records show no clearances under product code CCW in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code CCW, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260