BARD 4-WIRE URETEROSCOPIC STONE— 510(k) K921233
Substantially EquivalentC.R. Bard, Inc.
FDA 510(k) clearance K921233 for BARD 4-WIRE URETEROSCOPIC STONE, Substantially Equivalent on 1992-04-27. Applicant: C.R. Bard, Inc.. Device class: 2.
Clearance details
- Applicant
- C.R. Bard, Inc.
- Product code
- Code FFL
- Device class
- Class 2
- Regulation
- 21 CFR 876.4680
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Covington, GA, US
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Adverse events under product code FFL
product code FFL- Death
- 2
- Injury
- 270
- Malfunction
- 2,711
- Other
- 2
- Total
- 2,985
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.