SpeediCath Flex Coude— 510(k) K161672

Substantially Equivalent

Coloplast Corp.

FDA 510(k) clearance K161672 for SpeediCath Flex Coude, Substantially Equivalent on 2016-09-29. Applicant: Coloplast Corp..

Clearance details

Applicant: Coloplast Corp.
Product code: Code GBM
Advisory panel: Gastroenterology, Urology
Date received: 2016-06-09
Decision date: 2016-09-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Plymouth, MN, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code GBM

product code GBM

Injury: 397
Malfunction: 1,404
Total: 1,801

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.