PALA-NATE— 510(k) K923591

Substantially Equivalent

Gesco Intl., Inc.

FDA 510(k) clearance K923591 for PALA-NATE, Substantially Equivalent on 1993-03-16. Applicant: Gesco Intl., Inc..

Clearance details

Applicant: Gesco Intl., Inc.
Product code: Code BTR
Advisory panel: Anesthesiology
Date received: 1992-07-20
Decision date: 1993-03-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Antonio, TX, 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.