HYDROLOGY 5000— 510(k) K955339

Substantially Equivalent

Northgate Technologies, Inc.

FDA 510(k) clearance K955339 for HYDROLOGY 5000, Substantially Equivalent on 1996-03-13. Applicant: Northgate Technologies, Inc..

Clearance details

Applicant: Northgate Technologies, Inc.
Product code: Code GBX
Advisory panel: General, Plastic Surgery
Date received: 1995-11-20
Decision date: 1996-03-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Elgin, IL, US

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Adverse events under product code GBX

product code GBX

Death: 16
Injury: 583
Malfunction: 3,578
Other: 1
Total: 4,178

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.