Device, External Penile Rigidity

LKY · Class II — Moderate Risk (510(k) clearance required) · Gastroenterology, Urology · 21 CFR 876.5020

Classification

FDA Product Code: LKY
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 876.5020
Review panel: GU
Medical specialty: Gastroenterology, Urology
Submission type: 4
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

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.

Market data

Cleared 510(k) submissions: 87
Registered establishments: 48

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown