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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 a medical device manufactured by Rigicon, Inc.. It received FDA 510(k) clearance on 2019-04-15 under approval 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. It is manufactured by Rigicon, Inc.. The 510(k) number is K181673.

When was Rigi10 Malleable Penile Prosthesis approved by the FDA?

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

What company makes Rigi10 Malleable Penile Prosthesis?

Rigi10 Malleable Penile Prosthesis is manufactured by Rigicon, Inc..

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

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

Related Devices (Code: FAE)

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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