BARD ESKA JONAS SILICONE-SILVER PENILE PROSTHESIS— 510(k) K864040
Substantially EquivalentC.R. Bard, Inc.
FDA 510(k) clearance K864040 for BARD ESKA JONAS SILICONE-SILVER PENILE PROSTHESIS, Substantially Equivalent on 1986-10-24. Applicant: C.R. Bard, Inc.. Device class: 2.
Clearance details
- Applicant
- C.R. Bard, Inc.
- Product code
- Code FAE
- Device class
- Class 2
- Regulation
- 21 CFR 876.3630
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Murray Hill, NJ, US
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Adverse events under product code FAE
product code FAE- Injury
- 995
- Total
- 995
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.