ELEVATE PROLAPSE REPAIR SYSTEMS-APICAL NEEDLE PASSER SHEATH MODIFICATION— 510(k) K121612

Clearance details

Applicant

American Medical Systems

Product code

Code OTP

Device class

Class 3

Regulation

21 CFR 884.5980

Advisory panel

Obstetrics/Gynecology

Date received

2012-06-01

Decision date

2012-07-20

Decision

Substantially Equivalent

Clearance type

Special

Location

Minnetonka, MN, US

• K122459 — PINNACLE LITE PELVIC FLOOR REPAIR KIT, POSTERIOR UPHOLD LITE VAGINAL SUPPORT SYSTEM2012-12-13
• K112842 — AMS ELEVATE PC2011-10-25
• K103426 — LITE PELVIC FLOOR REPAIR KITS2011-09-14
• K112386 — EXAIR ANTERIOR AND POSTERIOR PROLAPSE REPAIR SYSTEM2011-09-08
• K102815 — SURELIFT PROLAPSE SYSTEM2011-07-07

• K140679 — SUREFLEX LITHOTRIPSY LASER FIBERS2014-06-20
• K131229 — SPARC SYSTEM AND MONARC, MONARC, AND MONARC C SYSTEMS2013-12-05
• K121805 — AMS LARGE PORE POLYPROPHLENE MESH2012-10-16
• K121641 — MINIARC PRO SINGLE-INCISION SLING SYSTEM2012-09-07
• K120870 — GREENLIGHT MOXY FIBER OPTIC2012-06-15

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 →