Device, External Penile Rigidity

Device Code: 1988

Product Code(s): LKY

Definition: Intended To Create Or Maintain Sufficient Penile Rigidity For Sexual Intercourse. These Include Vacuum Pumps, Constriction Rings, And Penile Splints, Which Are Mechanical, Powered Or Pneumatic Devices.

Device Classification Information

Device Type ID1988
Device NameDevice, External Penile Rigidity
Regulation DescriptionExternal Penile Rigidity Devices.
Regulation Medical SpecialtyGastroenterology/Urology
Review PanelGastroenterology/Urology
Premarket Review Office Of Device Evaluation (ODE)
Division Of Reproductive, Gastro-Renal, And Urological Devices (DRGUD)
Urology And Lithotripsy Devices Branch (ULDB)
Submission Type510(K) Exempt
CFR Regulation Number876.5020 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeLKY
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID1988
DeviceDevice, External Penile Rigidity
Product CodeLKY
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionExternal Penile Rigidity Devices.
CFR Regulation Number876.5020 [🔎]
Device Problems
Patient Device Interaction Problem
1
Device Operates Differently Than Expected
1
Adverse Event Without Identified Device Or Use Problem
1
Total Device Problems 3
TPLC Last Update: 2019-04-02 20:03:26

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