TRACHLIGHT STYLET AND TRACHEAL LIGHTWAND— 510(k) K962361

Substantially Equivalent

Laerdal Medical Corp.

FDA 510(k) clearance K962361 for TRACHLIGHT STYLET AND TRACHEAL LIGHTWAND, Substantially Equivalent on 1996-09-05. Applicant: Laerdal Medical Corp..

Clearance details

Applicant: Laerdal Medical Corp.
Product code: Code BSR
Advisory panel: Anesthesiology
Date received: 1996-06-19
Decision date: 1996-09-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wappingers Falls, NY, US

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Adverse events under product code BSR

product code BSR

Death: 2
Other: 1
Total: 3

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.