FLEX-NECK PD CATHETER— 510(k) K970159

Substantially Equivalent

Janin Group, Inc.

FDA 510(k) clearance K970159 for FLEX-NECK PD CATHETER, Substantially Equivalent on 1997-09-05. Applicant: Janin Group, Inc..

Clearance details

Applicant: Janin Group, Inc.
Product code: Code FJS
Advisory panel: Gastroenterology, Urology
Date received: 1997-01-16
Decision date: 1997-09-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Aurora, IL, US

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Adverse events under product code FJS

product code FJS

Death: 34
Injury: 652
Malfunction: 576
Other: 6
Total: 1,268

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.