← FDA DEVICE PRODUCT CODES

FDA PRODUCT CODE · CLASS II

LKY — Device, External Penile Rigidity

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 CLASS
Class II
REGULATION
21 CFR 876.5020
MEDICAL SPECIALTY
Gastroenterology, Urology
REVIEW PANEL
GU
— Implant— Life-sustaining— GMP-exempt— Third-party review eligible
0
510(K)/PMA CLEARANCES
0
RECALL ENTRIES

Related on SPEQ

Medical devices industry →Medical device quality (ISO 13485) →FDA device clearances →FDA enforcement & recalls →

Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.

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