NEZHAT-DORSEY SPECIMEN CONTAINER SYSTEM— 510(k) K951119

Substantially Equivalent

American Hydro-Surgical Instruments, Inc.

FDA 510(k) clearance K951119 for NEZHAT-DORSEY SPECIMEN CONTAINER SYSTEM, Substantially Equivalent on 1995-06-13. Applicant: American Hydro-Surgical Instruments, Inc..

Clearance details

Applicant: American Hydro-Surgical Instruments, Inc.
Product code: Code GCX
Advisory panel: General Hospital
Date received: 1995-03-10
Decision date: 1995-06-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Delray Beach, FL, US

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Adverse events under product code GCX

product code GCX

Death: 9
Malfunction: 592
Other: 2
Total: 603

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.