Cleared Traditional

SURGITEK ERECTEK TM EXTERNAL ERECTION DEVICE

K905015 · Surgitek · Gastroenterology & Urology

Dec 1990

Decision

51d

Days

Class 2

Risk

About This 510(k) Submission

K905015 is an FDA 510(k) clearance for the SURGITEK ERECTEK TM EXTERNAL ERECTION DEVICE, a Device, External Penile Rigidity (Class II — Special Controls, product code LKY), submitted by Surgitek (Racine, US). The FDA issued a Cleared decision on December 28, 1990, 51 days after receiving the submission on November 7, 1990. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5020.

Submission Details

510(k) Number	K905015 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 07, 1990
Decision Date	December 28, 1990
Days to Decision	51 days
Submission Type	Traditional
Review Panel	Gastroenterology & Urology (GU)
Summary	—

Device Classification

Product Code	LKY — Device, External Penile Rigidity
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 876.5020
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.