ROPE SYSTEM REVERSE OSMOSIS PERITONEAL SYSTEM— 510(k) K844630

Substantially Equivalent

Organon Teknika Corp.

FDA 510(k) clearance K844630 for ROPE SYSTEM REVERSE OSMOSIS PERITONEAL SYSTEM, Substantially Equivalent on 1985-03-12. Applicant: Organon Teknika Corp..

Clearance details

Applicant: Organon Teknika Corp.
Product code: Code FKX
Advisory panel: Gastroenterology, Urology
Date received: 1984-11-27
Decision date: 1985-03-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Oklahoma City, OK, US

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Adverse events under product code FKX

product code FKX

Death: 501
Injury: 6,720
Malfunction: 18,508
Other: 1
Total: 25,730

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.