SCOOP 1— 510(k) K981080

Substantially Equivalent

Transtracheal Systems

FDA 510(k) clearance K981080 for SCOOP 1, Substantially Equivalent on 1998-06-17. Applicant: Transtracheal Systems.

Clearance details

Applicant: Transtracheal Systems
Product code: Code BTO
Advisory panel: Anesthesiology
Date received: 1998-03-24
Decision date: 1998-06-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Boulder, CO, US

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Adverse events under product code BTO

product code BTO

Death: 14
Injury: 328
Malfunction: 1,851
Total: 2,193

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.