ORION SUCTION CATHETER KIT WITH STERILE SALINE— 510(k) K942274

Unknown

Regulatory & Marketing Services, Inc.

FDA 510(k) clearance K942274 for ORION SUCTION CATHETER KIT WITH STERILE SALINE, Unknown on 1994-06-02. Applicant: Regulatory & Marketing Services, Inc..

Clearance details

Applicant: Regulatory & Marketing Services, Inc.
Product code: Code GBX
Advisory panel: General, Plastic Surgery
Date received: 1994-05-10
Decision date: 1994-06-02
Decision: Unknown
Clearance type: Traditional
Location: Palm Harbor, FL, 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.