510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K905015Substantially Equivalent

Surgitek Erectek Tm External Erection Device

Surgitek, Racine WI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K905015 is the FDA 510(k) clearance record for SURGITEK ERECTEK TM EXTERNAL ERECTION DEVICE, a class II device, cleared for Surgitek on under FDA product code LKY (Device, External Penile Rigidity). FDA's definition for product code LKY reads: "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". FDA records list 29 510(k) clearances for Surgitek, from to . As of , FDA records show no recalls naming K905015.

Clearance record

Decision date
Received
(51 days to decision)
Product code
LKY Device, External Penile Rigidity
Regulation
21 CFR 876.5020
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Surgitek 3037 Mt. Pleasant St., Racine WI
Third party review
No

Clearances, product code LKY

Trailing 12 months

FDA records hold no clearances under product code LKY in the trailing twelve months.

FDA records show no clearances under product code LKY in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code LKY, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260