BARD ESKA JONAS SILICONE-SILVER PENILE PROSTHESIS— 510(k) K864040

Substantially Equivalent

C.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..

Clearance details

Applicant: C.R. Bard, Inc.
Product code: Code FAE
Advisory panel: Gastroenterology, Urology
Date received: 1986-10-16
Decision date: 1986-10-24
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, 2020-01-01 through 2026-04-23. 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.