Actreen Hi-Lite Intermittent Urinary Catheters— 510(k) K192577
Substantially EquivalentB.Braun Medical, Inc.
FDA 510(k) clearance K192577 for Actreen Hi-Lite Intermittent Urinary Catheters, Substantially Equivalent on 2020-05-07. Applicant: B.Braun Medical, Inc.. Device class: 2.
Clearance details
- Applicant
- B.Braun Medical, Inc.
- 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
- Special
- Location
- Allentown, PA, US
Recent devices under product code GBM
view all- K241734 — Wellead® Hydrophilic Intermittent Catheter Ready to Use; Wellead® Hydrophilic Intermittent Catheter Compact
- K213283 — GentleCath Air for Men Hydrophilic Intermittent Urinary Catheter
- K211436 — Intermittent Catheter (Not Finalized)
- K200820 — SpeediCath Compact Set
- K192904 — SpeediCath Compact Set
More clearances from B.Braun Medical, Inc.
view allAdverse 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.