SLIP-COAT STENTS— 510(k) K930731

Substantially Equivalent

Cook Urological, Inc.

FDA 510(k) clearance K930731 for SLIP-COAT STENTS, Substantially Equivalent on 1994-12-08. Applicant: Cook Urological, Inc..

Clearance details

Applicant: Cook Urological, Inc.
Product code: Code FAD
Advisory panel: Gastroenterology, Urology
Date received: 1993-02-11
Decision date: 1994-12-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Spencer, IN, US

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.