GREATBATCH SCIENTIFIC MRI COMPATIBLE FIBER OPTIC LARYNGOSCOPE HANDLE— 510(k) K970619

Substantially Equivalent

Wilson Greatbatch Technologies, Inc.

FDA 510(k) clearance K970619 for GREATBATCH SCIENTIFIC MRI COMPATIBLE FIBER OPTIC LARYNGOSCOPE HANDLE, Substantially Equivalent on 1997-11-19. Applicant: Wilson Greatbatch Technologies, Inc..

Clearance details

Applicant: Wilson Greatbatch Technologies, Inc.
Product code: Code CCW
Advisory panel: Anesthesiology
Date received: 1997-02-18
Decision date: 1997-11-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Clarence, NY, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code CCW

product code CCW

Death: 31
Injury: 136
Malfunction: 3,703
Other: 1
Total: 3,871

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.