7-510-25 HYSTEROMED TUBING KIT— 510(k) K931606

Substantially Equivalent

Nortech

FDA 510(k) clearance K931606 for 7-510-25 HYSTEROMED TUBING KIT, Substantially Equivalent on 1994-01-24. Applicant: Nortech.

Clearance details

Applicant: Nortech
Product code: Code HIG
Advisory panel: Obstetrics/Gynecology
Date received: 1993-04-01
Decision date: 1994-01-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Arlington Heights, IL, US

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Adverse events under product code HIG

product code HIG

Death: 8
Other: 2
Total: 10

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.