Tactra Penile Prosthesis, 9.5 mm Device, Tactra Penile Prosthesis, 11 mm Device, Tactra Penile Prosthesis, 13 mm Device— 510(k) K183619

Name: FDA 510(k) clearance K183619
Creator: U.S. Food and Drug Administration
Published: 2019-04-16

Substantially Equivalent

Boston Scientific Corporation

FDA 510(k) clearance K183619 for Tactra Penile Prosthesis, 9.5 mm Device, Tactra Penile Prosthesis, 11 mm Device, Tactra Penile Prosthesis, 13 mm Device, Substantially Equivalent on 2019-04-16. Applicant: Boston Scientific Corporation. Device class: 2.

Clearance details

Applicant: Boston Scientific Corporation
Product code: Code FAE
Device class: Class 2
Regulation: 21 CFR 876.3630
Advisory panel: Gastroenterology, Urology
Date received: 2018-12-26
Decision date: 2019-04-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minnetonka, MN, US

Download summary PDF View on FDA.gov ↗

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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.