MENTOR NOVASILK MESH— 510(k) K053414

Clearance details

Applicant

Mentor Corp.

Product code

Code OTP

Device class

Class 3

Regulation

21 CFR 884.5980

Advisory panel

Obstetrics/Gynecology

Date received

2005-12-07

Decision date

2005-12-27

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Santa Barbara, CA, US

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• K121612 — ELEVATE PROLAPSE REPAIR SYSTEMS-APICAL NEEDLE PASSER SHEATH MODIFICATION2012-07-20
• K112842 — AMS ELEVATE PC2011-10-25
• K103426 — LITE PELVIC FLOOR REPAIR KITS2011-09-14
• K112386 — EXAIR ANTERIOR AND POSTERIOR PROLAPSE REPAIR SYSTEM2011-09-08

• K130813 — MENTOR CPX 4 BREAST TISSUE EXPANDERS AND MENTOR CPX 4 WITH SUTURE TABS BREAST TISSUE EXPANDERS2013-04-11
• K050008 — MENTOR SELF-CATH HYDROGEL INTERMITTENT CATHETER2005-06-03
• K042851 — MENTOR OBTAPE TRANS-OBTURATOR SURGICAL KIT2004-11-09
• K040959 — MENTOR GENESIS PENILE PROSTHESIS2004-10-29
• K031767 — MENTOR OBTAPE TRANS-OBTURATOR TAPE2003-07-17

Injury

1,061

Total

1,061

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →