RocaJJ Soft Stents— 510(k) K173734

Substantially Equivalent

Promepla Sam

FDA 510(k) clearance K173734 for RocaJJ Soft Stents, Substantially Equivalent on 2018-03-12. Applicant: Promepla Sam.

Clearance details

Applicant: Promepla Sam
Product code: Code FAD
Advisory panel: Gastroenterology, Urology
Date received: 2017-12-06
Decision date: 2018-03-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Monaco, MC

Download summary PDF View on FDA.gov ↗

Adverse events under product code FAD

product code FAD

Death: 2
Injury: 858
Malfunction: 2,651
Other: 1
Total: 3,512

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.