PS X SERIES (BASIC COMPONENTS AND CATHETER), PD X SERIES (CATHETER WITH ALL COMPONENTS)— 510(k) K121383

Unknown

Medical Components, Inc.

FDA 510(k) clearance K121383 for PS X SERIES (BASIC COMPONENTS AND CATHETER), PD X SERIES (CATHETER WITH ALL COMPONENTS), Unknown on 2012-09-05. Applicant: Medical Components, Inc..

Clearance details

Applicant: Medical Components, Inc.
Product code: Code FJS
Advisory panel: Gastroenterology, Urology
Date received: 2012-05-08
Decision date: 2012-09-05
Decision: Unknown
Clearance type: Traditional
Location: Harleysville, PA, US

Download summary PDF View on FDA.gov ↗

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.