GentleCath Air for Men Hydrophilic Intermittent Urinary Catheter— 510(k) K213283
Substantially EquivalentConvatec Limited
FDA 510(k) clearance K213283 for GentleCath Air for Men Hydrophilic Intermittent Urinary Catheter, Substantially Equivalent on 2022-06-22. Applicant: Convatec Limited. Device class: 2.
Clearance details
- Applicant
- Convatec Limited
- Product code
- Code GBM
- Device class
- Class 2
- Regulation
- 21 CFR 876.5130
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Deeside, GB
Recent devices under product code GBM
view allMore clearances from Convatec Limited
view all- K252943 — GentleCath Air for Men; GentleCath Glide Intermittent Catheter; GentleCath Air for Women
- K250891 — Cure Catheter Insertion Kit (K1) +12 more
- K190114 — Flexi-Seal PROTECT PLUS Fecal Management System (with ENFit Connector)
- K180205 — AVELLE Negative Pressure Wound Therapy System
- K181206 — GentleCath Glide Intermittent Urinary Catheter
Adverse events under product code GBM
product code GBM- Injury
- 397
- Malfunction
- 1,404
- Total
- 1,801
Source: openFDA MAUDE database, through . 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.