Erectaid

FDA 510(k) K803111 · Burditt & Calkins-Siemens-Elema

Substantially Equivalent

510(k) numberK803111

Submission

Device name
Erectaid
Applicant
Burditt & Calkins-Siemens-Elema
Chicago, IL, US
Received
December 10, 1980
Decision date
January 23, 1981
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
FAE – Prosthesis, Penile
Device class
Class II (moderate risk)
Regulation
21 CFR 876.3630
Specialty
Gastroenterology, Urology
Implant
Yes

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K183619Tactra Penile Prosthesis, 9.5 mm Device, Tactra Penile Prosthesis, 11 mm Device, Tactra…FAE · Traditional Boston Scientific Corporation04/16/2019SE
K181673Rigi10 Malleable Penile ProsthesisFAE · Abbreviated Rigicon, Inc.04/15/2019SE
K090663Ams Spectra Concealable Penile ProsthesisFAE · Special American Medical Systems, Inc.04/09/2009SE
K082006Ams Spectra Concealable Penile ProsthesisFAE · Traditional American Medical Systems, Inc.10/20/2008SE
K040959Mentor Genesis Penile ProsthesisFAE · Traditional Mentor Corp.10/29/2004SE
K963328Ams Ambicor Penile ProsthesisFAE · Traditional American Medical Systems, Inc.12/04/1996SE
K953640Duna II Penile ProsthesisFAE · Traditional Dacomed Corp.10/27/1995SE
K951716Ams 650 Mallerable Peniel ProsthesisFAE · Traditional American Medical Systems, Inc.07/06/1995SE
K920420Dura II Penile ProsthesisFAE · Traditional Dacomed Corp.04/16/1992SE
K912935Ams Malleable 600 and 600M Penile ProsthesisFAE · Traditional American Medical Systems, Inc.03/18/1992SE

More from American Medical Systems, Inc.

510(k)DeviceDecision
K833519Pulse Generator Model 688DXY · Traditional 01/30/1984SE
K833155Rayden Medical Mini Pulse Volume RecordDSB · Traditional 01/26/1984SE
K830344Siemens-Elma Pulse Generator #718DXY · Traditional 05/27/1983SE
K823435Mon-A-Therm Myocardial Temp. SensorKRB · Traditional 12/30/1982SE
K823591Ameda Hand Breast PumpHGY · Traditional 12/28/1982SE
K822239Coaxial Bipolar Pacing ElectrodeDTB · Traditional 10/04/1982SE
K821712Informed Remote Field Unit Model IFM1000BTY · Traditional 07/26/1982SE
K802607Terperatur Sensing DeviceFLL · Traditional 11/19/1980SE
K760787Liberator/StrollerBYJ · Traditional 10/22/1976SE

Questions and answers

When was Erectaid cleared by the FDA?

Erectaid (K803111) received a 510(k) decision of Substantially Equivalent on January 23, 1981, 44 days after the submission was received.

What is the product code of K803111?

The FDA product code is FAE – Prosthesis, Penile, a Class II (moderate risk) device regulated under 21 CFR 876.3630.