SPEEDICATH COMPACT SET (12/18 FR)— 510(k) K121458

Substantially Equivalent

Coloplast A/S

FDA 510(k) clearance K121458 for SPEEDICATH COMPACT SET (12/18 FR), Substantially Equivalent on 2012-10-01. Applicant: Coloplast A/S.

Clearance details

Applicant: Coloplast A/S
Product code: Code GBM
Advisory panel: Gastroenterology, Urology
Date received: 2012-05-16
Decision date: 2012-10-01
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.