GentleCath Glide Intermittent Urinary Catheter— 510(k) K181206

Substantially Equivalent

Convatec Limited

FDA 510(k) clearance K181206 for GentleCath Glide Intermittent Urinary Catheter, Substantially Equivalent on 2018-08-16. Applicant: Convatec Limited.

Clearance details

Applicant: Convatec Limited
Product code: Code GBM
Advisory panel: Gastroenterology, Urology
Date received: 2018-05-07
Decision date: 2018-08-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Deeside, GB

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.