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FDA 510(k)

Rigi10 Malleable Penile Prosthesis

K-Number: K181673 · 2019-04-15

ApplicantRigicon, Inc.
Decision Date2019-04-15
Product CodeFAE
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Rigi10 Malleable Penile Prosthesis is the device name listed in this FDA 510(k) record. The listed applicant is Rigicon, Inc.. It received FDA 510(k) clearance on 2019-04-15 under 510(k) number K181673. The device is classified under product code FAE. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Rigi10 Malleable Penile Prosthesis?

Rigi10 Malleable Penile Prosthesis is a medical device that received FDA 510(k) clearance on 2019-04-15. The listed applicant is Rigicon, Inc.. The 510(k) number is K181673.

When did Rigi10 Malleable Penile Prosthesis receive FDA 510(k) clearance?

Rigi10 Malleable Penile Prosthesis received FDA 510(k) clearance on 2019-04-15, under 510(k) number K181673.

Who is the listed applicant for Rigi10 Malleable Penile Prosthesis?

The FDA 510(k) record lists Rigicon, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Rigi10 Malleable Penile Prosthesis?

The FDA product code for Rigi10 Malleable Penile Prosthesis is FAE.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT05574868Rigicon Infla10® Three-Piece Inflatable Penile Prosthesis (ERASE ED)RECRUITINGNCT07273773Evaluation of the Rigicon Infla10® Inflatable Penile Prosthesis (IPP) for Erectile DysfunctionRECRUITING

Related Devices (Code: FAE)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K183619Tactra Penile Prosthesis, 9.5 mm Device, Tactra Penile Prosthesis, 11 mm Device, Tactra Penile Prosthesis, 13 mm DeviceBoston Scientific Corporation

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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