C-FLEX PENROSE DRAINAGE TUBE— 510(k) K833061

Substantially Equivalent

Concept, Inc.

FDA 510(k) clearance K833061 for C-FLEX PENROSE DRAINAGE TUBE, Substantially Equivalent on 1983-11-07. Applicant: Concept, Inc..

Clearance details

Applicant: Concept, Inc.
Product code: Code FFA
Advisory panel: Gastroenterology, Urology
Date received: 1983-09-09
Decision date: 1983-11-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Adverse events under product code FFA

product code FFA

Death: 3
Total: 3

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.