HALL TRANSCEERVICAL SAFE ACCESS CANNULA(TM)— 510(k) K904645

Substantially Equivalent

Hall Medical Laboratories

FDA 510(k) clearance K904645 for HALL TRANSCEERVICAL SAFE ACCESS CANNULA(TM), Substantially Equivalent on 1991-02-26. Applicant: Hall Medical Laboratories.

Clearance details

Applicant: Hall Medical Laboratories
Product code: Code HET
Advisory panel: Obstetrics/Gynecology
Date received: 1990-10-11
Decision date: 1991-02-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shawnee, KS, US

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Adverse events under product code HET

product code HET

Malfunction: 10,504
Total: 10,504

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.