SPARC SYSTEM AND MONARC, MONARC, AND MONARC C SYSTEMS— 510(k) K131229

Clearance details

Applicant

American Medical Systems

Product code

Code OTN

Device class

Class 2

Regulation

21 CFR 878.3300

Advisory panel

General, Plastic Surgery

Date received

2013-04-30

Decision date

2013-12-05

Decision

Substantially Equivalent

Clearance type

Special

Location

Minnetonka, MN, US

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• K211223 — Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra System2021-07-21

• K140679 — SUREFLEX LITHOTRIPSY LASER FIBERS2014-06-20
• K121805 — AMS LARGE PORE POLYPROPHLENE MESH2012-10-16
• K121641 — MINIARC PRO SINGLE-INCISION SLING SYSTEM2012-09-07
• K121612 — ELEVATE PROLAPSE REPAIR SYSTEMS-APICAL NEEDLE PASSER SHEATH MODIFICATION2012-07-20
• K120870 — GREENLIGHT MOXY FIBER OPTIC2012-06-15

Injury

6,630

Total

6,630

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 →

• Z-0805-2015 — AMS Monarc + Subfascial Hammock with Tensioning Suture REF 72404193 and AMS Monarc C Subfascial Hammock with Tensioning Suture REF 72404195, Sterilized Using Ethylene Oxide. The Monarc + and Monarc C subfascial hammocks are sterile, single use procedure kits, each consisting of two stainless steel, curved needle passers. The tip portion of each needle passer is configured to allow for secure placement of the connectors. Each needle passer has a plastic handle attached. The system also contains a sling assembly including one piece of loosely knitted polypropylene mesh, two removable plastic insertion sheaths attached to the mesh, and two connectors attached to the insertion sheaths. The mesh is constructed of polypropylene monofilament. An absorbable tensioning suture is threaded into the length of the mesh to allow for tensioning adjustment of the mesh after placement in the patient is achieved. The plastic covering also affords convenient travel of the mesh through the tissue. The connectors are attached to the tip portions of the Monarc needle passers during the procedure. The loosely knitted polypropylene mesh is intended to remain in the body as a permanent implant. The mesh component is not absorbed or degraded by the action of tissue in-growth or tissue enzymes.Class II·Terminated·American Medical Systems, Inc.·20141015

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K131229.