Cleared Traditional

K183619 - Tactra Penile Prosthesis, 9.5 mm Device, Tactra Penile Prosthesis, 11 mm Device, Tactra Penile Prosthesis, 13 mm Device

K183619 is an FDA 510(k) clearance for Tactra Penile Prosthesis, manufactured by Boston Scientific Corporation. The device is a Class 2 Gastroenterology & Urology device with product code FAE cleared through the Traditional 510(k) pathway after a 111-day FDA review.

K183619 · Boston Scientific Corporation · Gastroenterology & Urology device
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Optimized for regulatory review, auditing and printing
Apr 2019
Decision
111d
Days
Class 2
Risk

K183619 is an FDA 510(k) clearance for the Tactra Penile Prosthesis, 9.5 mm Device, Tactra Penile Prosthesis, 11 mm Devi.... Classified as Prosthesis, Penile (product code FAE), Class II - Special Controls.

Submitted by Boston Scientific Corporation (Minnetonka, US). The FDA issued a Cleared decision on April 16, 2019 after a review of 111 days - within the typical 510(k) review window.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.3630 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Boston Scientific Corporation devices

FDA 510(k) Submission Details - K183619

510(k) Number K183619 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 26, 2018
Decision Date April 16, 2019
Days to Decision 111 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
20d faster than avg
Panel avg: 131d · This submission: 111d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FAE Device Classification - Class 2, Special Controls

Product Code FAE Prosthesis, Penile
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.3630
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - FAE Prosthesis, Penile

All 28
Devices cleared under the same product code (FAE) and FDA review panel - the closest regulatory comparables to K183619.
Rigi10 Malleable Penile Prosthesis
K181673 · Rigicon, Inc. · Apr 2019
AMS SPECTRA CONCEALABLE PENILE PROSTHESIS
K090663 · American Medical Systems, Inc. · Apr 2009
AMS SPECTRA CONCEALABLE PENILE PROSTHESIS
K082006 · American Medical Systems, Inc. · Oct 2008
MENTOR GENESIS PENILE PROSTHESIS
K040959 · Mentor Corp. · Oct 2004
AMS AMBICOR PENILE PROSTHESIS
K963328 · American Medical Systems, Inc. · Dec 1996
DUNA II PENILE PROSTHESIS
K953640 · Dacomed Corp. · Oct 1995