TRACHLIGHT STYLET & TRACHEAL LIGHTWAND (ORIGINAL APPLICATION NAME: STYLETT & TRACHEAL LIGHTWAND)— 510(k) K954771

Substantially Equivalent

Laerdal Medical Corp.

FDA 510(k) clearance K954771 for TRACHLIGHT STYLET & TRACHEAL LIGHTWAND (ORIGINAL APPLICATION NAME: STYLETT & TRACHEAL LIGHTWAND), Substantially Equivalent on 1996-05-09. Applicant: Laerdal Medical Corp..

Clearance details

Applicant: Laerdal Medical Corp.
Product code: Code BSR
Advisory panel: Anesthesiology
Date received: 1995-10-17
Decision date: 1996-05-09
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.