BUSSE HOSPITAL DISPOSABLES URETHRAL CATHETER— 510(k) K041464
Substantially EquivalentBusse Hospital Disposables
FDA 510(k) clearance K041464 for BUSSE HOSPITAL DISPOSABLES URETHRAL CATHETER, Substantially Equivalent on 2004-11-05. Applicant: Busse Hospital Disposables.
Clearance details
- Applicant
- Busse Hospital Disposables
- Product code
- Code EZD
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Hauppauge, NY, US
Adverse events under product code EZD
product code EZD- Injury
- 864
- Malfunction
- 2,210
- Total
- 3,074
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.