EXTERNAL MALE CATHETER— 510(k) K852051
Substantially EquivalentBuffalo Medical Specialties Mfg., Inc.
FDA 510(k) clearance K852051 for EXTERNAL MALE CATHETER, Substantially Equivalent on 1985-08-22. Applicant: Buffalo Medical Specialties Mfg., Inc..
Clearance details
- Applicant
- Buffalo Medical Specialties Mfg., Inc.
- Product code
- Code KNX
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Clearwater, FL, US
Adverse events under product code KNX
product code KNX- Malfunction
- 1,064
- Total
- 1,064
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.