Cleared Abbreviated

K181673 - Rigi10 Malleable Penile Prosthesis (FDA 510(k) Clearance)

Class II Gastroenterology & Urology device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K181673 · Rigicon, Inc. · Gastroenterology & Urology device
Apr 2019
Decision
294d
Days
Class 2
Risk

K181673 is an FDA 510(k) clearance for the Rigi10 Malleable Penile Prosthesis. Classified as Prosthesis, Penile (product code FAE), Class II - Special Controls.

Submitted by Rigicon, Inc. (Hauppauge, US). The FDA issued a Cleared decision on April 15, 2019 after a review of 294 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.3630 - the FDA gastroenterology and urology device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

Submission Details

510(k) Number K181673 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 25, 2018
Decision Date April 15, 2019
Days to Decision 294 days
Submission Type Abbreviated
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
138d slower than avg
Panel avg: 156d · This submission: 294d
Pathway characteristics
Standards-based clearance path.

Device Classification

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.