PINT BOTTLE WELL— 510(k) K781364

Substantially Equivalent

Baxa Corp., Sub. of Cook Group, Inc.

FDA 510(k) clearance K781364 for PINT BOTTLE WELL, Substantially Equivalent on 1978-10-17. Applicant: Baxa Corp., Sub. of Cook Group, Inc..

Clearance details

Applicant: Baxa Corp., Sub. of Cook Group, Inc.
Product code: Code KYX
Advisory panel: General Hospital
Date received: 1978-08-07
Decision date: 1978-10-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Adverse events under product code KYX

product code KYX

Death: 3
Other: 8
Total: 11

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.