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Mentor Genesis Penile Prosthesis

by Mentor Corp. United States 510(k)

510(k) K040959 Product code FAE

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK040959 Date29 Oct 2004ClearedStatusActive

Coverage

1 jurisdiction

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  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

1 recall · FDA

    • Terminated Z-1538-2015 FDA Class II initiated 9 Apr 2015

    Several lots of the 9.5 mm Genesis Malleable Penile Prosthesis were mislabeled. The Retail Box and Patient Labels indicate a size 9 mm, instead of 9.5 mm. The device size is printed directly on the individual prosthesis tray during the packaging process and states the correct size, 9.5 mm.

Specification

510(k) · synced 10 Oct 2026

510(k) Number
FDA Product Code
FAE
Device Class
Class II
Regulation
21 CFR Part 876.3630
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

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Properties & raw data

Show properties, registry sources and raw records

Sources (1)

  • FDA 510(k) K040959 24 fields · synced 10 Oct 2026