FOSSA URETERAL OPEN STENTS— 510(k) K072293

Name: FDA 510(k) clearance K072293
Creator: U.S. Food and Drug Administration
Published: 2008-08-06

Substantially Equivalent

Fossa Medical, Inc.

FDA 510(k) clearance K072293 for FOSSA URETERAL OPEN STENTS, Substantially Equivalent on 2008-08-06. Applicant: Fossa Medical, Inc.. Device class: 2.

Clearance details

Applicant: Fossa Medical, Inc.
Product code: Code FAD
Device class: Class 2
Regulation: 21 CFR 876.4620
Advisory panel: Gastroenterology, Urology
Date received: 2007-08-16
Decision date: 2008-08-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Boston, MA, US

Download summary PDF View on FDA.gov ↗

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More clearances from Fossa Medical, Inc.

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K033368 — FOSSA URETERAL OPEN LUMEN STENT2003-11-26
K031292 — MODIFICATION TO FOSSA URETERAL STONE SWEEPER2003-05-22

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.