GENERAL SURGICAL INSTRUMENTS— 510(k) K894670

Substantially Equivalent

Nopa Instruments

FDA 510(k) clearance K894670 for GENERAL SURGICAL INSTRUMENTS, Substantially Equivalent on 1989-08-10. Applicant: Nopa Instruments.

Clearance details

Applicant: Nopa Instruments
Product code: Code DXC
Advisory panel: Cardiovascular
Date received: 1989-06-02
Decision date: 1989-08-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Haverford, PA, US

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Adverse events under product code DXC

product code DXC

Death: 14
Injury: 442
Malfunction: 2,209
Other: 1
Total: 2,666

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.