510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K040959Substantially Equivalent

Mentor Genesis Penile Prosthesis

Mentor, Santa Barbara CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K040959 is the FDA 510(k) clearance record for MENTOR GENESIS PENILE PROSTHESIS, a class II device, cleared for Mentor Corp. on under FDA product code FAE (Prosthesis, Penile). FDA records list 65 510(k) clearances for Mentor Corp., from to . As of , FDA records show one recall naming K040959.

Clearance record

Decision date
Received
(199 days to decision)
Product code
FAE Prosthesis, Penile
Regulation
21 CFR 876.3630
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Mentor Corp. 201 Mentor Dr., Santa Barbara CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code FAE

Trailing 12 months

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

FDA records show no clearances under product code FAE in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code FAE, 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