Salle Intraoperative Pyeloplasty Stent Set— 510(k) K170010

Name: FDA 510(k) clearance K170010
Creator: U.S. Food and Drug Administration
Published: 2017-08-28

Substantially Equivalent

Cook Incorporated

FDA 510(k) clearance K170010 for Salle Intraoperative Pyeloplasty Stent Set, Substantially Equivalent on 2017-08-28. Applicant: Cook Incorporated. Device class: 2.

Clearance details

Applicant: Cook Incorporated
Product code: Code FAD
Device class: Class 2
Regulation: 21 CFR 876.4620
Advisory panel: Gastroenterology, Urology
Date received: 2017-01-03
Decision date: 2017-08-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bloomington, IN, US

Download summary PDF View on FDA.gov ↗

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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.