CONNELL-STEPHENS ENDO ANESS TUBE— 510(k) K895132

Substantially Equivalent

The Traumafuse Co.

FDA 510(k) clearance K895132 for CONNELL-STEPHENS ENDO ANESS TUBE, Substantially Equivalent on 1989-10-13. Applicant: The Traumafuse Co..

Clearance details

Applicant: The Traumafuse Co.
Product code: Code BTR
Advisory panel: Anesthesiology
Date received: 1989-08-17
Decision date: 1989-10-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Allentown, PA, US

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Adverse events under product code BTR

product code BTR

Death: 92
Injury: 1,263
Malfunction: 7,475
Other: 2
Total: 8,832

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.