Product Code: FAE FDA class 2 21 CFR 876.3630

Prosthesis, Penile

Gastroenterology, Urology

The Penile Prosthesis (product code FAE) is a surgically implanted device used to treat erectile dysfunction, providing mechanical support to enable sexual function. It is an FDA Class 2 device (moderate risk), requiring 510(k) premarket clearance. It is regulated under 21 CFR 876.3630 in the Gastroenterology and Urology specialty. This device is designated as an implant.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: FAE
Device Class: FDA class 2
Regulation Number: 876.3630
Medical Specialty: Gastroenterology, Urology
Review Panel: GU
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✓

Implant

✗

Life Sustain/Support

✗

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 32 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K183619	Tactra Penile Prosthesis, 9.5 mm Device, Tactra Penile Prosthesis, 11 mm Device, Tactra Penile Prosthesis, 13 mm Device	Apr 16, 2019	Substantially Equivalent	Boston Scientific Corporation
K181673	Rigi10 Malleable Penile Prosthesis	Apr 15, 2019	Substantially Equivalent	Rigicon, Inc.
K090663	AMS SPECTRA CONCEALABLE PENILE PROSTHESIS	Apr 09, 2009	Substantially Equivalent	American Medical Systems, Inc.
K082006	AMS SPECTRA CONCEALABLE PENILE PROSTHESIS	Oct 20, 2008	Substantially Equivalent	American Medical Systems, Inc.
K040959	MENTOR GENESIS PENILE PROSTHESIS	Oct 29, 2004	Substantially Equivalent	Mentor Corp.
K963328	AMS AMBICOR PENILE PROSTHESIS	Dec 04, 1996	Substantially Equivalent	American Medical Systems, Inc.
K953640	DUNA II PENILE PROSTHESIS	Oct 27, 1995	Substantially Equivalent	Dacomed Corp.
K951716	AMS 650 MALLERABLE PENIEL PROSTHESIS	Jul 06, 1995	Substantially Equivalent	American Medical Systems, Inc.
K920420	DURA II PENILE PROSTHESIS	Apr 16, 1992	Substantially Equivalent	Dacomed Corp.
K912935	AMS MALLEABLE 600 AND 600M PENILE PROSTHESIS	Mar 18, 1992	Substantially Equivalent	American Medical Systems, Inc.
K912344	MODIFIED DURAPHASE(TM) IMPLANTED PENILE PROSTHESIS	Oct 11, 1991	Substantially Equivalent	Dacomed Corp.
K910214	AMS 700 ULTREX(TM) PRECONNECTED PENILE PROSTHESIS	Apr 25, 1991	Substantially Equivalent	American Medical Corp.
K904262	MINNOW PENILE IMPLANT PROTECTOR	Dec 13, 1990	Substantially Equivalent	Ruja-Med Medical Marketing
K900371	MENTOR MODIFIED MALLEABLE PENILE PROSTHESES	Nov 02, 1990	Substantially Equivalent	Mentor Corp.
K901482	700 ULTREX PENILE PROSTHESIS 12MM DIAMETER	Jun 27, 1990	Substantially Equivalent	American Medical Systems, Inc.
K896941	AMS DYNAFLEX SELF CONTAINED PENILE PROSTHESIS	Mar 06, 1990	Substantially Equivalent	American Medical Systems, Inc.
K890402	MENTOR CYLINDER PROTECTOR TOOL (INFLATABLE PENILE)	Aug 03, 1989	Substantially Equivalent	Mentor Corp.
K871653	DURAPHASE PENILE PROSTHESIS	Sep 18, 1987	Substantially Equivalent	Dacomed Corp.
K864040	BARD ESKA JONAS SILICONE-SILVER PENILE PROSTHESIS	Oct 24, 1986	Substantially Equivalent	C.R. Bard, Inc.
K860517	MENTOR CORPORAL DILATORS	Mar 11, 1986	Substantially Equivalent	Mentor Corp.
K850019	OMNI PHASE PENILE PROSTHESIS	Apr 09, 1985	Substantially Equivalent	Dacomed Corp.
K843280	MALLEABLE PENILE PROSTHESIS	Oct 24, 1984	Substantially Equivalent	Mentor Corp.
K834347	FLEXI-FLATE PENILE IMPLANT	Apr 02, 1984	Substantially Equivalent	Surgitek
K834504	ESKA JONAS SILICON-SILVER PENILE	Feb 04, 1984	Substantially Equivalent	Dacomed Corp.
K832043	SURGIKEK PENILE PROSTHESIS TAIL EXTEND	Oct 20, 1983	Substantially Equivalent	Medical Engineering Corp.
K831660	AMS MALLEABLE PENILE PROSTHESIS	Aug 08, 1983	Substantially Equivalent	American Medical Systems, Inc.
K830917	SURGITEK SIZER FOR PENILE PROSTHESIS	Apr 12, 1983	Substantially Equivalent	Medical Engineering Corp.
K830048	INFLATABLE PENILE PROSTH. - CYLINDER	Apr 12, 1983	Substantially Equivalent	American Medical Systems, Inc.
K821628	THE INFLATABLE PENILE PROSTHESIS	Aug 10, 1982	Substantially Equivalent	American Medical Systems, Inc.
K820081	ESKA JONAS SILICONE-SILVER PENILE PROST	Jan 25, 1982	Substantially Equivalent	Dacomed Corp.
K803111	ERECTAID	Jan 23, 1981	Substantially Equivalent	Burditt & Calkins-Siemens-Elema
K792724	AMS MALLEABLE OR JONAS SILICONE-SILVER	Sep 09, 1980	Substantially Equivalent	American Medical Systems, Inc.