Data / Medical devices / Device, External Penile Rigidity

Device, External Penile Rigidity (LKY): 36 FDA-registered makers in 11 countries

36 establishments in 11 countries are registered with the FDA to make Device, External Penile Rigidity (product code LKY, Class 2, 21 CFR 876.5020). 1 of them has a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 87 510(k) clearances under this code, the latest on August 25, 2004, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.

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Product code

LKY

Device class

2

Regulation

876.5020

Medical specialty

Gastroenterology, Urology

Makers by country

Makers of Device, External Penile Rigidity

Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.

Updated August 25, 2004. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.