DISPOSABLE COLLECTION BOTTLE W/TUBING— 510(k) K822311

Substantially Equivalent

Ohio Medical Products

FDA 510(k) clearance K822311 for DISPOSABLE COLLECTION BOTTLE W/TUBING, Substantially Equivalent on 1982-08-20. Applicant: Ohio Medical Products.

Clearance details

Applicant: Ohio Medical Products
Product code: Code GCX
Advisory panel: General Hospital
Date received: 1982-08-03
Decision date: 1982-08-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, 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.