UNIVERSAL URETHRAL CATHETER— 510(k) K946282
Substantially EquivalentLouisville Laboratories, Inc.
FDA 510(k) clearance K946282 for UNIVERSAL URETHRAL CATHETER, Substantially Equivalent on 1995-03-31. Applicant: Louisville Laboratories, Inc.. Device class: 2.
Clearance details
- Applicant
- Louisville Laboratories, Inc.
- Product code
- Code EZC
- Device class
- Class 2
- Regulation
- 21 CFR 876.5130
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Louisville, KY, US
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Adverse events under product code EZC
product code EZC- Injury
- 772
- Malfunction
- 6,262
- Other
- 1
- Total
- 7,035
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.